List of NDC API details of Pradaxa Active Pharmaceutical Ingredient listed on PharmaCompass.com

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Chemistry

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Also known as: Dabigatran etexilate mesylate, 872728-81-9, Pradaxa, Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid, Dtxsid20236248, Ex-a1966
Molecular Formula
C35H45N7O8S
Molecular Weight
723.8  g/mol
InChI Key
XETBXHPXHHOLOE-UHFFFAOYSA-N

Dabigatran Etexilate Mesylate
A THROMBIN inhibitor which acts by binding and blocking thrombogenic activity and the prevention of thrombus formation. It is used to reduce the risk of stroke and systemic EMBOLISM in patients with nonvalvular atrial fibrillation.
1 2D Structure

Dabigatran Etexilate Mesylate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
ethyl 3-[[2-[[4-[(Z)-N'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic acid
2.1.2 InChI
InChI=1S/C34H41N7O5.CH4O3S/c1-4-6-7-10-21-46-34(44)39-32(35)24-12-15-26(16-13-24)37-23-30-38-27-22-25(14-17-28(27)40(30)3)33(43)41(20-18-31(42)45-5-2)29-11-8-9-19-36-29;1-5(2,3)4/h8-9,11-17,19,22,37H,4-7,10,18,20-21,23H2,1-3H3,(H2,35,39,44);1H3,(H,2,3,4)
2.1.3 InChI Key
XETBXHPXHHOLOE-UHFFFAOYSA-N
2.1.4 Canonical SMILES
CCCCCCOC(=O)N=C(C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)N.CS(=O)(=O)O
2.1.5 Isomeric SMILES
CCCCCCOC(=O)/N=C(/C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=CC=N4)\N.CS(=O)(=O)O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Bibr 1048

2. Dabigatran

3. Dabigatran Etexilate

4. Dabigatran Etexilate Mesylate

5. Etexilate Mesylate, Dabigatran

6. Etexilate, Dabigatran

7. Mesylate, Dabigatran Etexilate

8. N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1h-benzimidazol-5-yl)carbonyl)-n-2-pyridinyl-beta-alanine

9. Pradaxa

2.2.2 Depositor-Supplied Synonyms

1. Dabigatran Etexilate Mesylate

2. 872728-81-9

3. Pradaxa

4. Ethyl 3-[[2-[[4-[(z)-n'-hexoxycarbonylcarbamimidoyl]anilino]methyl]-1-methylbenzimidazole-5-carbonyl]-pyridin-2-ylamino]propanoate;methanesulfonic Acid

5. Dtxsid20236248

6. Ex-a1966

7. Mfcd25424070

8. S5960

9. Ccg-213236

10. Cs-w004358

11. (z)-ethyl 3-(2-(((4-(n'-((hexyloxy)carbonyl)carbamimidoyl)phenyl)amino)methyl)-1-methyl-n-(pyridin-2-yl)-1h-benzo[d]imidazole-5-carboxamido)propanoate Methanesulfonate

12. 728p819

2.3 Create Date
2006-10-26
3 Chemical and Physical Properties
Molecular Weight 723.8 g/mol
Molecular Formula C35H45N7O8S
Hydrogen Bond Donor Count3
Hydrogen Bond Acceptor Count11
Rotatable Bond Count17
Exact Mass723.30503259 g/mol
Monoisotopic Mass723.30503259 g/mol
Topological Polar Surface Area217 Ų
Heavy Atom Count51
Formal Charge0
Complexity1100
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count1
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NamePradaxa
PubMed HealthDabigatran (By mouth)
Drug ClassesAnticoagulant
Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
Active IngredientDabigatran etexilate mesylate
Dosage FormCapsule
RouteOral
Strengtheq 150mg base; eq 75mg base
Market StatusPrescription
CompanyBoehringer Ingelheim

2 of 2  
Drug NamePradaxa
PubMed HealthDabigatran (By mouth)
Drug ClassesAnticoagulant
Drug LabelThe chemical name for dabigatran etexilate mesylate, a direct thrombin inhibitor, is -Alanine, N-[[2-[[[4-[[[(hexyloxy)carbonyl]amino]iminomethyl] phenyl]amino]methyl]-1-methyl-1H-benzimidazol-5-yl]carbonyl]-N-2-pyridinyl-,ethyl ester, methanesulfo...
Active IngredientDabigatran etexilate mesylate
Dosage FormCapsule
RouteOral
Strengtheq 150mg base; eq 75mg base
Market StatusPrescription
CompanyBoehringer Ingelheim

4.2 Drug Indication

Pradaxa 75 mg

- Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

Pradaxa 110 mg

- Primary prevention of venous thromboembolic events in adult patients who have undergone elective total hip replacement surgery or total knee replacement surgery.

- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.

Pradaxa 150 mg

- Prevention of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation (NVAF), with one or more risk factors, such as prior stroke or transient ischemic attack (TIA); age 75 years; heart failure (NYHA Class II); diabetes mellitus; hypertension.

- Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE), and prevention of recurrent DVT and PE in adults.


5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Antithrombins

Endogenous factors and drugs that directly inhibit the action of THROMBIN, usually by blocking its enzymatic activity. They are distinguished from INDIRECT THROMBIN INHIBITORS, such as HEPARIN, which act by enhancing the inhibitory effects of antithrombins. (See all compounds classified as Antithrombins.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Thrombin Inhibitors [MoA]; Direct Thrombin Inhibitor [EPC]
5.3 ATC Code

B01AE07


USDMF

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 37633

Submission : 2022-10-31

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2014-07-07

Pay. Date : 2014-04-21

DMF Number : 27960

Submission : 2014-04-04

Status : Active

Type : II

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DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 28352

Submission : 2014-07-07

Status : Active

Type : II

Neuland

04

Boulder Peptide 2024
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05

Apotex Pharmachem Inc

Canada

USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2014-08-25

Pay. Date : 2014-03-28

DMF Number : 28029

Submission : 2014-03-28

Status : Active

Type : II

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GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 27892

Submission : 2014-03-25

Status : Inactive

Type : II

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Hetero Drugs Ltd

India

USDMF

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GDUFA

DMF Review : Complete

Rev. Date : 2014-10-13

Pay. Date : 2014-08-25

DMF Number : 28177

Submission : 2014-08-05

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2014-10-01

Pay. Date : 2014-07-03

DMF Number : 28039

Submission : 2014-04-11

Status : Active

Type : II

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GDUFA

DMF Review : Complete

Rev. Date : 2014-07-15

Pay. Date : 2014-04-22

DMF Number : 28118

Submission : 2014-04-27

Status : Active

Type : II

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EU WC

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Dabigatran Etexilate Mesylate IH

Date of Issue : 2022-06-17

Valid Till : 2025-07-07

Written Confirmation Number : WC-0067

Address of the Firm : Chemical Technical Operations Unit-VI, APIIC Industrial Estate, Pydibhimavaram V...

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02

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Dabigatran Etaxilate Mesilate (IH)

Date of Issue : 2022-06-08

Valid Till : 2025-06-16

Written Confirmation Number : WC-0037

Address of the Firm : Unit-II, Plot No.92-94, 257-259, IDA Pashmylaram, Isnapur Village, Patancheru Ma...

Neuland

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Dabigatran Etexilate Mesylate

Date of Issue : 2022-06-17

Valid Till : 2025-07-02

Written Confirmation Number : WC-0082

Address of the Firm : API Division Kharakhadi, Plot No. 842-843, Kharakhadi, Padra Vadodara-391 450, G...

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Dabigatran Etexilate Mesylate IH

Date of Issue : 2021-01-08

Valid Till : 2023-11-23

Written Confirmation Number : WC-0310

Address of the Firm : Plot No.Z-103/I Dahej Sez, Phase-II Dahej, Dist Bharuch, Gujarat

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Hetero Drugs

India
Boulder Peptide 2024
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Hetero Drugs

India
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Dabigatran Etexilate Mesylate (IH)

Date of Issue : 2019-08-09

Valid Till : 2025-08-08

Written Confirmation Number : WC-0066

Address of the Firm : Plot No. 1, Hetero SEZ Infrastructure Ltd., Narasapuram, Visakhapatnam-531 081, ...

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Dabigatran Etexilate Oxalate IH

Date of Issue : 2022-01-04

Valid Till : 2022-07-14

Written Confirmation Number : WC-0021A4

Address of the Firm : Sy. No.317&323, Rudraram Village, Patancheru Mandal, Sangaredy District-502329 T...

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Natco Pharma

India
Boulder Peptide 2024
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Natco Pharma

India
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Dabigatran etexilate mesilate IH

Date of Issue : 2019-06-26

Valid Till : 2022-06-25

Written Confirmation Number : WC-0014

Address of the Firm : Mekaguda (V) kothur (M) Mahabood nagar Dist, Telangana State India

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Dabigatran Etexilate Mesylate IH

Date of Issue : 2022-06-29

Valid Till : 2025-07-02

Written Confirmation Number : WC-0123

Address of the Firm : Sy. Nos. 7-70, 70/1 & 70/2, Digwal Village, Kohir Mandai, Sangareddy District, T...

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Dabigatran Etexilate Mesylate

Date of Issue : 2022-06-08

Valid Till : 2025-07-02

Written Confirmation Number : WC-0112

Address of the Firm : Plot No. 69/A-2, GIDC Industrial Estate, Vapi, Dist-Valsad-396 175, Gujarat, Ind...

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Dabigatran Etexilate Mesylate IH

Date of Issue : 2022-06-08

Valid Till : 2025-07-25

Written Confirmation Number : WC-0159

Address of the Firm : A-7/A-8, MIDC, Ahmednagar-414 111, Maharashtra State

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KDMF

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Dabigatran etexilate mesylate

Registrant Name : Sangjin Trading Co., Ltd.

Registration Date : 2021-07-05

Registration Number : Number 583-29-ND

Manufacturer Name : Dr. Reddy's Laboratories Lim...

Manufacturer Address : CTD-VI, APIIC Industrial Estate, Pydhibeemavaram, Ranasthalam Mandal, Srikakulam Dist...

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Biocon

India
Boulder Peptide 2024
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Biocon

India
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Dabigatran etexilate mesylate

Registrant Name : Bahnsen Co., Ltd.

Registration Date : 2020-07-14

Registration Number : Number 720-4-ND

Manufacturer Name : Biocon Limited

Manufacturer Address : Plot No. 213 – 215 and 216/B Phase – II, IDA, Pashamylaram, Sangareddy District-5...

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Dabigatran etexilate

Registrant Name : Dasan Pharmaceutical Co., Ltd.

Registration Date : 2017-06-29

Registration Number : 2243-9-ND

Manufacturer Name : Dasan Pharmaceutical Co., Lt...

Manufacturer Address : [Partial process consignment manufacturing (manufacturing requester) (small distribut...

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Dabigatran etexilate mesylate

Registrant Name : Aging Life Science Co., Ltd.

Registration Date : 2018-02-02

Registration Number : Number 434-2-ND

Manufacturer Name : Glenmark Life Sciences Limit...

Manufacturer Address : Plot No. Z-103/I, DAHEJ SEZ, Phase II, City : DAHEJ, Dist : BHARUCH, GUJARATE, INDIA

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Hanmi Pharmaceutical

South Korea
Boulder Peptide 2024
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Hanmi Pharmaceutical

South Korea
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Dabigatran etexilate hemisuccinate

Registrant Name : Hanmi Fine Chemical Co., Ltd.

Registration Date : 2018-01-16

Registration Number : 1444-8-ND

Manufacturer Name : Hanmi Fine Chemical Co., Ltd...

Manufacturer Address : 57 Gyeongje-ro, Siheung-si, Gyeonggi-do (1248-10)@[Starting material manufacturer] Fe...

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Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2018-02-12

Registration Number : Number 258-6-ND

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Dabigatran etexilate mesylate

Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

Registration Date : 2018-05-29

Registration Number : Number 258-6-ND(1)

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Dabigatran etexilate mesylate

Registrant Name : Pharmapia Co., Ltd.

Registration Date : 2019-03-20

Registration Number : Wed258-10-ND

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Boulder Peptide 2024
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Dabigatran etexilate mesylate

Registrant Name : Kookjeon Pharmaceutical Co., Ltd.

Registration Date : 2020-08-20

Registration Number : Number 258-10-ND(1)

Manufacturer Name : MSN Laboratories Private Lim...

Manufacturer Address : Sy. No. 317, 320, 321, 322, 323, 604 & 605, Rudraram (Village), Patancheru (Mandal), ...

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Dabigatran etexilate mesylate

Registrant Name : Hwail Pharmaceutical Co., Ltd.

Registration Date : 2018-01-22

Registration Number : Number 331-14-ND

Manufacturer Name : Piramal Pharma Limited (Pira...

Manufacturer Address : Sy. Nos. 7-70, 70/1 and 70/2, Digwal Village, Kohir Mandal, Sangareddy District, Tela...

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API Reference Price

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INC","customerCountry":"INDIA","quantity":"18.69","actualQuantity":"18.69","unit":"KGS","unitRateFc":"2177","totalValueFC":"30506.3","currency":"CAD","unitRateINR":"133450.1","date":"30-Jan-2023","totalValueINR":"2494182.37","totalValueInUsd":"30506.3","indian_port":"BANGALORE AIR","hs_no":"29339990","bill_no":"4404124","productDescription":"API","marketType":"REGULATED MARKET","country":"CANADA","selfForZScoreResived":"Pharma Grade","supplierPort":"NA","supplierAddress":"","customerAddress":"SITE NO.1,BOMMASANDRA INDL.AREA,IV ,PHASE,JIGANI LINK ROAD ANEKAL TALU"},{"dataSource":"API Import","activeIngredients":"","year":"2023","qtr":"Q2","strtotime":1686853800,"product":"P\/NO.: DABIGATRAN ETEXILATE MESYLATE 43% IR PELLETS","address":"SY NO.810, PLOT NO.19 B1 B2 B3,IDA PHASE II, PATANCHERU,","city":"HYDERABAD,TELANGANA","supplier":"JSC NOBEL ALMATINSKAYA FARMAZEVTICHESKAYA","supplierCountry":"INDIA","foreign_port":"NA","customer":"ANWITA DRUGS & CHEMICALS PVT 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C-24,","city":"HYDERABAD. AP","supplier":"CHEMO","supplierCountry":"INDIA","foreign_port":"MADRID","customer":"MSN LABORATORIES","customerCountry":"INDIA","quantity":"100.00","actualQuantity":"100","unit":"KGS","unitRateFc":"1000","totalValueFC":"102900.1","currency":"USD","unitRateINR":"85543.3","date":"12-Sep-2023","totalValueINR":"8554332.27","totalValueInUsd":"102900.1","indian_port":"Hyderabad Air","hs_no":"29333990","bill_no":"7787428","productDescription":"Re-Import","marketType":"REGULATED MARKET","country":"INDIA","selfForZScoreResived":"Pharma Grade","supplierPort":"MADRID","supplierAddress":"MANUEL POMBO ANGULO,3RD FLOORMADRID-28050 SPAINSDNF ES","customerAddress":"MSN HOUSE, PLOT NO. C-24,"}]
12-Jan-2021
21-Aug-2024
KGS
overview
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Average Price (USD/KGS)

Number of Transactions

Total Quantity (KGS)

Total Value (USD)

Quantity (KGS) & Unit rate (USD/KGS) over time

API Imports and Exports

Importing Country Total Quantity
(KGS)
Average Price
(USD/KGS)
Number of Transactions

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DOSAGE - CAPSULE;ORAL - EQ 110MG BASE

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