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Hydrocodone Bitartrate

Synopsis, Chemistry

APIs // Active Pharmaceutical Ingredients

22 API Suppliers, 17 USDMF, 1 KDMF, 17 NDC API, 10 Listed Suppliers

DEVELOPMENTS

5 Drug(s) in Development

5 Drug(s) in Development

INTERMEDIATES

1 Suppliers

1 Suppliers

DOSSIERs // Finished Dosage Formulations

344 Dossiers, 337 FDA Orange Book, 3 Canada, 4 Listed Dossiers

DRUG PRODUCT COMPOSITION

CAPSULE, EXTENDED RELEASE;ORAL - 10MG, CAPSULE, EXTENDED RELEASE;ORAL - 15MG, CAPSULE, EXTENDED RELEASE;ORAL - 20MG, CAPSULE, EXTENDED RELEASE;ORAL - 30MG, CAPSULE, EXTENDED RELEASE;ORAL - 40MG, CAPSULE, EXTENDED RELEASE;ORAL - 50MG, SOLUTION;ORAL - 4MG/5ML;5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML, SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML, SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**, TABLET;ORAL - 1.5MG;5MG

CAPSULE, EXTENDED RELEASE;ORAL - 10MG
CAPSULE, EXTENDED RELEASE;ORAL - 15MG
CAPSULE, EXTENDED RELEASE;ORAL - 20MG
CAPSULE, EXTENDED RELEASE;ORAL - 30MG
CAPSULE, EXTENDED RELEASE;ORAL - 40MG
CAPSULE, EXTENDED RELEASE;ORAL - 50MG
SOLUTION;ORAL - 4MG/5ML;5MG/5ML
SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML
SOLUTION;ORAL - 200MG/5ML;2.5MG/5ML;30MG/5ML
SOLUTION;ORAL - 4MG/5ML;5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
SOLUTION;ORAL - 5MG/5ML;60MG/5ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
TABLET;ORAL - 1.5MG;5MG

RELATED EXCIPIENT COMPANIES

Suppliers, 38 Kerry, 35 BASF, 35 Roquette, 16 Microlex e.U, 16 Corel Pharma Chem, 14 Seppic, 14 Actylis, 13 Gangwal Chemicals, 12 Sigachi Industries, 11 Gangwal Healthcare, 10 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 8 Boai NKY Pharmaceuticals Ltd, 8 Nanjing Well Pharmaceutical, 7 DFE Pharma, 7 Ideal Cures Pvt Ltd, 6 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 6 SPI Pharma, 6 Lonza Capsugel, 5 Rochem International Inc, 4 Pharmatrans-Sanaq, 4 Ingredion Pharma Solutions, 4 Prachin Chemical, 4 DKSH, 4 Vasa Pharmachem, 4 Kima Chemical, 4 ACG Worldwide, 3 Ulanqab Kema New Material, 3 The Dow Chemical Company, 3 Zhejiang Huakang Pharmaceutical, 2 Pharm-RX Chemical, 2 Qualicaps, 2 Alcedo Pharmachem, 2 Seqens, 2 Finar, 2 Nomisma Healthcare, 2 Jai Radhe Sales, 1 Clariant, 1 Shijiazhuang Huaxu Pharmaceutical, 1 Aeon Procare, 1 Evonik, 1 Shanghai Welltone Material Technology Co., Ltd, 1 Bioplus Life Sciences, 1 Pfanstiehl, 1 Nanjing Bold Chemical, 1 Huzhou Sunflower Pharmaceutical Co. Ltd, 1 Vertellus, 1 Qianhao Chemical (Hebei) Co., Ltd

EXCIPIENTS BY APPLICATIONS

89 Fillers, Diluents & Binders, 61 Coating Systems & Additives, 44 Direct Compression, 43 Disintegrants & Superdisintegrants, 43 Controlled & Modified Release, 33 Granulation, 32 Thickeners and Stabilizers, 30 Solubilizers, 29 Taste Masking, 28 Film Formers & Plasticizers, 21 Parenteral, 20 Lubricants & Glidants, 18 Topical, 15 Co-Processed Excipients, 12 Chewable & Orodispersible Aids, 9 Empty Capsules, 8 API Stability Enhancers, 7 Emulsifying Agents, 5 Rheology Modifiers, 4 Vegetarian Capsules, 3 Surfactant & Foaming Agents, 2 Coloring Agents, 1 Soft Gelatin

GLOBAL SALES INFORMATION

17 US Medicaid Prescriptions

17 US Medicaid Prescriptions

MARKET PLACE

3 APIs, 2 DOSSIERS // FDF

PATENTS

254 US Patents

254 US Patents

ANALYTICAL SOLUTION(s)

3 USP Standards, 7 Other Ref. Standards

DIGITAL CONTENT

3 Data Compilations & Company Tracker #PharmaFlow, 96 News

API SUPPLIERS

API Suppliers

US DMFs Filed

CEP/COS Certifications

JDMFs Filed

Other Certificates

Other Suppliers

API REF. PRICE (USD / KG)

API Market Place

INTERMEDIATES

DOSSIERS // FDF

USA (Orange Book)

337

Europe

Canada

Australia

South Africa

Uploaded Dossiers

GLOBAL SALES (USD Million)

U.S. Medicaid

150.00

Annual Reports

66.00

FDF Market Place

EXCIPIENTS

329

PATENTS & EXCLUSIVITIES

USFDA Orange Book Patents

254

USFDA Exclusivities

DIGITAL CONTENT

Blog #PharmaFlow

News

REF STANDARD

EDQM

USP

Other Listed Suppliers

SERVICES

Also known as: (4r,4ar,7ar,12bs)-9-methoxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;2,3-dihydroxybutanedioic acid, .codon, Schembl154972, Chembl2062267

Molecular Formula

C₂₂H₂₇NO₉

Molecular Weight

449.4 g/mol

InChI Key

OJHZNMVJJKMFGX-RNWHKREASA-N

Narcotic analgesic related to CODEINE, but more potent and more addicting by weight. It is used also as cough suppressant.

1 2D Structure

Hydrocodone Bitartrate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aR,7aR,12bS)-9-methoxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;2,3-dihydroxybutanedioic acid

2.1.2 InChI

InChI=1S/C18H21NO3.C4H6O6/c1-19-8-7-18-11-4-5-13(20)17(18)22-16-14(21-2)6-3-10(15(16)18)9-12(11)19;5-1(3(7)8)2(6)4(9)10/h3,6,11-12,17H,4-5,7-9H2,1-2H3;1-2,5-6H,(H,7,8)(H,9,10)/t11-,12+,17-,18-;/m0./s1

2.1.3 InChI Key

OJHZNMVJJKMFGX-RNWHKREASA-N

2.1.4 Canonical SMILES

CN1CCC23C4C1CC5=C2C(=C(C=C5)OC)OC3C(=O)CC4.C(C(C(=O)O)O)(C(=O)O)O

2.1.5 Isomeric SMILES

CN1CC[C@]23[C@@H]4[C@H]1CC5=C2C(=C(C=C5)OC)O[C@H]3C(=O)CC4.C(C(C(=O)O)O)(C(=O)O)O

2.2 Synonyms

2.2.1 MeSH Synonyms

1. Codinovo

2. Dicodid

3. Dihydrocodeinone

4. Hycodan

5. Hycon

6. Hydrocodeinonebitartrate

7. Hydrocodon

8. Hydrocodone

9. Hydrocodone Tartrate (1:1), Hydrate (2:5)

10. Hydrocon

11. Robidone

2.2.2 Depositor-Supplied Synonyms

1. (4r,4ar,7ar,12bs)-9-methoxy-3-methyl-1,2,4,4a,5,6,7a,13-octahydro-4,12-methanobenzofuro[3,2-e]isoquinolin-7-one;2,3-dihydroxybutanedioic Acid

2. .codon

3. Schembl154972

4. Chembl2062267

2.2.3 Other Synonyms

1. Hydrocone

2. Multacodin

3. Hydrocodone

2.3 Create Date

2007-12-05

3 Chemical and Physical Properties

Molecular Formula	C₂₂H₂₇NO₉
Molecular Weight	449.4 g/mol
Hydrogen Bond Donor Count	4
Hydrogen Bond Acceptor Count	10
Rotatable Bond Count	4
Exact Mass	449.16858144 g/mol
Monoisotopic Mass	449.16858144 g/mol
Topological Polar Surface Area	154 Å²
Heavy Atom Count	32
Formal Charge	0
Complexity	642
Isotope Atom Count	0
Defined Atom Stereocenter Count	4
Undefined Atom Stereocenter Count	2
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Pharmacology and Biochemistry

4.1 MeSH Pharmacological Classification

Analgesics, Opioid

Compounds with activity like OPIATE ALKALOIDS, acting at OPIOID RECEPTORS. Properties include induction of ANALGESIA or NARCOSIS. (See all compounds classified as Analgesics, Opioid.)

Antitussive Agents

Agents that suppress cough. They act centrally on the medullary cough center. EXPECTORANTS, also used in the treatment of cough, act locally. (See all compounds classified as Antitussive Agents.)

Narcotics

Agents that induce NARCOSIS. Narcotics include agents that cause somnolence or induced sleep (STUPOR); natural or synthetic derivatives of OPIUM or MORPHINE or any substance that has such effects. They are potent inducers of ANALGESIA and OPIOID-RELATED DISORDERS. (See all compounds classified as Narcotics.)

4.2 FDA Pharmacological Classification

4.2.1 Pharmacological Classes

Opioid Agonists [MoA]; Opioid Agonist [EPC]