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Chemistry

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Also known as: Esomeprazole sodium, Esomeprazole (sodium), H199/18 sodium, Esomeprazole (as sodium), Esomeprazole sodium [usan], 161796-78-7
Molecular Formula
C17H18N3NaO3S
Molecular Weight
367.4  g/mol
InChI Key
RYXPMWYHEBGTRV-JIDHJSLPSA-N
FDA UNII
L2C9GWQ43H

Esomeprazole Sodium
The S-isomer of omeprazole.
1 2D Structure

Esomeprazole Sodium

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
sodium;5-methoxy-2-[(S)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide
2.1.2 InChI
InChI=1S/C17H18N3O3S.Na/c1-10-8-18-15(11(2)16(10)23-4)9-24(21)17-19-13-6-5-12(22-3)7-14(13)20-17;/h5-8H,9H2,1-4H3;/q-1;+1/t24-;/m0./s1
2.1.3 InChI Key
RYXPMWYHEBGTRV-JIDHJSLPSA-N
2.1.4 Canonical SMILES
CC1=CN=C(C(=C1OC)C)CS(=O)C2=NC3=C([N-]2)C=CC(=C3)OC.[Na+]
2.1.5 Isomeric SMILES
CC1=CN=C(C(=C1OC)C)C[S@](=O)C2=NC3=C([N-]2)C=CC(=C3)OC.[Na+]
2.2 Other Identifiers
2.2.1 UNII
L2C9GWQ43H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Esomeprazole

2. Esomeprazole Magnesium

3. Esomeprazole Potassium

4. Esomeprazole Sodium

5. Esomeprazole Strontium

6. Esomeprazole Strontium Anhydrous

7. Nexium

8. Strontium, Esomeprazole

2.3.2 Depositor-Supplied Synonyms

1. Esomeprazole Sodium

2. Esomeprazole (sodium)

3. H199/18 Sodium

4. Esomeprazole (as Sodium)

5. Esomeprazole Sodium [usan]

6. 161796-78-7

7. Esomeprazole Sodium (usan)

8. (s)-omeprazole Sodium Salt

9. L2c9gwq43h

10. Sodium;5-methoxy-2-[(s)-(4-methoxy-3,5-dimethylpyridin-2-yl)methylsulfinyl]benzimidazol-1-ide

11. Nexium Iv (tn)

12. 1h-benzimidazole, 5-methoxy-2-((s)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt

13. 5-methoxy-2-((s)-((4-methoxy-3,5-dimethyl-2-pyridyl)methyl)sulfinyl)-1h-benzimidazole, Sodium Salt

14. Chembl1200470

15. Esomeprazole Sodium [vandf]

16. Esomeprazole Sodium [mart.]

17. Esomeprazole Sodium [who-dd]

18. S2233

19. Ccg-268253

20. Esomeprazole Sodium [orange Book]

21. Esomeprazole Sodium [ep Monograph]

22. Hy-17023

23. O0560

24. 1h-benzimidazole, 6-methoxy-2-((s)-((4-methoxy-3,5-dimethyl-2-pyridinyl)methyl)sulfinyl)-, Sodium Salt (1:1)

25. D04056

26. Q-100194

27. Q27282619

28. 5-methoxy-2-[(s)-[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1h-benzimidazole Sodium Salt

2.4 Create Date
2008-02-05
3 Chemical and Physical Properties
Molecular Weight 367.4 g/mol
Molecular Formula C17H18N3NaO3S
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count7
Rotatable Bond Count5
Exact Mass367.09665690 g/mol
Monoisotopic Mass367.09665690 g/mol
Topological Polar Surface Area81.5 Ų
Heavy Atom Count25
Formal Charge0
Complexity459
Isotope Atom Count0
Defined Atom Stereocenter Count1
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count2
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameEsomeprazole sodium
Drug LabelThe active ingredient in esomeprazole sodium for injection is (S)-5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isome...
Active IngredientEsomeprazole sodium
Dosage FormInjectable
RouteIntravenous
Strengtheq 20mg base/vial; eq 40mg base/vial
Market StatusPrescription
CompanySun Pharma Global

2 of 2  
Drug NameEsomeprazole sodium
Drug LabelThe active ingredient in esomeprazole sodium for injection is (S)-5-methoxy-2[[(4-methoxy-3,5-dimethyl-2-pyridinyl)-methyl]sulfinyl]-1 H-benzimidazole sodium, a proton pump inhibitor that inhibits gastric acid secretion. Esomeprazole is the S-isome...
Active IngredientEsomeprazole sodium
Dosage FormInjectable
RouteIntravenous
Strengtheq 20mg base/vial; eq 40mg base/vial
Market StatusPrescription
CompanySun Pharma Global

5 Pharmacology and Biochemistry
5.1 MeSH Pharmacological Classification

Anti-Ulcer Agents

Various agents with different action mechanisms used to treat or ameliorate PEPTIC ULCER or irritation of the gastrointestinal tract. This has included ANTIBIOTICS to treat HELICOBACTER INFECTIONS; HISTAMINE H2 ANTAGONISTS to reduce GASTRIC ACID secretion; and ANTACIDS for symptomatic relief. (See all compounds classified as Anti-Ulcer Agents.)


Proton Pump Inhibitors

Compounds that inhibit H(+)-K(+)-EXCHANGING ATPASE. They are used as ANTI-ULCER AGENTS and sometimes in place of HISTAMINE H2 ANTAGONISTS for GASTROESOPHAGEAL REFLUX. (See all compounds classified as Proton Pump Inhibitors.)


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Proton Pump Inhibitor [EPC]; Proton Pump Inhibitors [MoA]; Cytochrome P450 2C19 Inhibitors [MoA]

API Reference Price

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05-Jan-2022
26-Feb-2026
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 20MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 20MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21689

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DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BAS...DOSAGE - INJECTABLE;INTRAVENOUS - EQ 40MG BASE/VIAL **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

USFDA APPLICATION NUMBER - 21689

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ABOUT THIS PAGE

Looking for 161796-78-7 / Esomeprazole Sodium API manufacturers, exporters & distributors?

Esomeprazole Sodium manufacturers, exporters & distributors 1

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PharmaCompass offers a list of Esomeprazole Sodium API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Esomeprazole Sodium manufacturer or Esomeprazole Sodium supplier for your needs.

Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Esomeprazole Sodium manufacturer or Esomeprazole Sodium supplier.

PharmaCompass also assists you with knowing the Esomeprazole Sodium API Price utilized in the formulation of products. Esomeprazole Sodium API Price is not always fixed or binding as the Esomeprazole Sodium Price is obtained through a variety of data sources. The Esomeprazole Sodium Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.

API | Excipient name

Esomeprazole Sodium

Synonyms

Esomeprazole (sodium), H199/18 sodium, Esomeprazole (as sodium), Esomeprazole sodium [usan], 161796-78-7, Esomeprazole sodium (usan)

Cas Number

161796-78-7

Unique Ingredient Identifier (UNII)

L2C9GWQ43H

About Esomeprazole Sodium

The S-isomer of omeprazole.

Nexium IV (TN) Manufacturers

A Nexium IV (TN) manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Nexium IV (TN), including repackagers and relabelers. The FDA regulates Nexium IV (TN) manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Nexium IV (TN) API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Nexium IV (TN) manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Nexium IV (TN) Suppliers

A Nexium IV (TN) supplier is an individual or a company that provides Nexium IV (TN) active pharmaceutical ingredient (API) or Nexium IV (TN) finished formulations upon request. The Nexium IV (TN) suppliers may include Nexium IV (TN) API manufacturers, exporters, distributors and traders.

click here to find a list of Nexium IV (TN) suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Nexium IV (TN) USDMF

A Nexium IV (TN) DMF (Drug Master File) is a document detailing the whole manufacturing process of Nexium IV (TN) active pharmaceutical ingredient (API) in detail. Different forms of Nexium IV (TN) DMFs exist exist since differing nations have different regulations, such as Nexium IV (TN) USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Nexium IV (TN) DMF submitted to regulatory agencies in the US is known as a USDMF. Nexium IV (TN) USDMF includes data on Nexium IV (TN)'s chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Nexium IV (TN) USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Nexium IV (TN) suppliers with USDMF on PharmaCompass.

Nexium IV (TN) KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Nexium IV (TN) Drug Master File in Korea (Nexium IV (TN) KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Nexium IV (TN). The MFDS reviews the Nexium IV (TN) KDMF as part of the drug registration process and uses the information provided in the Nexium IV (TN) KDMF to evaluate the safety and efficacy of the drug.

After submitting a Nexium IV (TN) KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Nexium IV (TN) API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Nexium IV (TN) suppliers with KDMF on PharmaCompass.

Nexium IV (TN) CEP

A Nexium IV (TN) CEP of the European Pharmacopoeia monograph is often referred to as a Nexium IV (TN) Certificate of Suitability (COS). The purpose of a Nexium IV (TN) CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Nexium IV (TN) EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Nexium IV (TN) to their clients by showing that a Nexium IV (TN) CEP has been issued for it. The manufacturer submits a Nexium IV (TN) CEP (COS) as part of the market authorization procedure, and it takes on the role of a Nexium IV (TN) CEP holder for the record. Additionally, the data presented in the Nexium IV (TN) CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Nexium IV (TN) DMF.

A Nexium IV (TN) CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Nexium IV (TN) CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.

click here to find a list of Nexium IV (TN) suppliers with CEP (COS) on PharmaCompass.

Nexium IV (TN) WC

A Nexium IV (TN) written confirmation (Nexium IV (TN) WC) is an official document issued by a regulatory agency to a Nexium IV (TN) manufacturer, verifying that the manufacturing facility of a Nexium IV (TN) active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Nexium IV (TN) APIs or Nexium IV (TN) finished pharmaceutical products to another nation, regulatory agencies frequently require a Nexium IV (TN) WC (written confirmation) as part of the regulatory process.

click here to find a list of Nexium IV (TN) suppliers with Written Confirmation (WC) on PharmaCompass.

Nexium IV (TN) NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Nexium IV (TN) as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Nexium IV (TN) API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Nexium IV (TN) as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Nexium IV (TN) and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Nexium IV (TN) NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Nexium IV (TN) suppliers with NDC on PharmaCompass.

Nexium IV (TN) GMP

Nexium IV (TN) Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Nexium IV (TN) GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Nexium IV (TN) GMP manufacturer or Nexium IV (TN) GMP API supplier for your needs.

Nexium IV (TN) CoA

A Nexium IV (TN) CoA (Certificate of Analysis) is a formal document that attests to Nexium IV (TN)'s compliance with Nexium IV (TN) specifications and serves as a tool for batch-level quality control.

Nexium IV (TN) CoA mostly includes findings from lab analyses of a specific batch. For each Nexium IV (TN) CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Nexium IV (TN) may be tested according to a variety of international standards, such as European Pharmacopoeia (Nexium IV (TN) EP), Nexium IV (TN) JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Nexium IV (TN) USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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