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TABLET;ORAL - 15MG, TABLET;ORAL - 30MG, TABLET;ORAL - 60MG

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TABLET;ORAL - 15MG
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TABLET;ORAL - 60MG

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4 SPI Pharma, 1 DKSH, 2 Faran Shimi Pharmaceutical, 9 Gangwal Healthcare, 1 Aeon Procare, 4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd, 2 BASF, 2 DFE Pharma, 5 Gangwal Chemicals, 1 Ideal Cures Pvt Ltd, 2 Ingredion Pharma Solutions, 4 Kerry, 9 Microlex e.U, 1 Pharmatrans-Sanaq, 2 Pluviaendo, 2 Prachin Chemical, 17 Roquette, 1 Seppic, 3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd, 9 Sigachi Industries, 2 Vasa Pharmachem

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13 Thickeners and Stabilizers
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3 Emulsifying Agents
1 API Stability Enhancers
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Synopsis

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Chemistry

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Also known as: Codeine sulfate, 3-methylmorphine sulfate salt, Schembl24864, Chembl284671

Molecular Formula

C₁₈H₂₃NO₇S

Molecular Weight

397.4 g/mol

InChI Key

REJWPZYIFAQSIK-FFHNEAJVSA-N

Codeine Sulfate is the sulfate salt form of codeine, a naturally occurring phenanthrene alkaloid and opioid agonist with analgesic, antidiarrheal and antitussive activity. Codeine sulfate mimics the actions of opioids by binding to the opioid receptors at many sites within the central nervous system (CNS). Stimulation of the mu-subtype opioid receptor stimulates the exchange of GTP for GDP on the G-protein complex and subsequently inhibits adenylate cyclase. This results in a decrease in intracellular cAMP and leads to a reduction in the release of neurotransmitters such as substance P, GABA, dopamine, acetylcholine and noradrenaline. The analgesic effect of codeine sulfate is likely due to its metabolite morphine, which induces opening of G-protein-coupled inwardly rectifying potassium (GIRK) channels and blocks the opening of N-type voltage-gated calcium channels, thereby resulting in hyperpolarization and reduced neuronal excitability.

1 2D Structure

Codeine Sulfate

2 Identification

2.1 Computed Descriptors

2.1.1 IUPAC Name

(4R,4aR,7S,7aR,12bS)-9-methoxy-3-methyl-2,4,4a,7,7a,13-hexahydro-1H-4,12-methanobenzofuro[3,2-e]isoquinolin-7-ol;sulfuric acid

2.1.2 InChI

InChI=1S/C18H21NO3.H2O4S/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;1-5(2,3)4/h3-6,11-13,17,20H,7-9H2,1-2H3;(H2,1,2,3,4)/t11-,12+,13-,17-,18-;/m0./s1

2.1.3 InChI Key

REJWPZYIFAQSIK-FFHNEAJVSA-N

2.1.4 Canonical SMILES

CN1CCC23C4C1CC5=C2C(=C(C=C5)OC)OC3C(C=C4)O.OS(=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]3[C@H](C=C4)O.OS(=O)(=O)O

2.2 Synonyms

2.2.1 Depositor-Supplied Synonyms

1. Codeine Sulfate

2. 3-methylmorphine Sulfate Salt

3. Schembl24864

4. Chembl284671

2.3 Create Date

2006-03-21

3 Chemical and Physical Properties

Molecular Formula	C₁₈H₂₃NO₇S
Molecular Weight	397.4 g/mol
Hydrogen Bond Donor Count	3
Hydrogen Bond Acceptor Count	8
Rotatable Bond Count	1
Exact Mass	397.11952325 g/mol
Monoisotopic Mass	397.11952325 g/mol
Topological Polar Surface Area	125 Å²
Heavy Atom Count	27
Formal Charge	0
Complexity	590
Isotope Atom Count	0
Defined Atom Stereocenter Count	5
Undefined Atom Stereocenter Count	0
Defined Bond Stereocenter Count	0
Undefined Bond Stereocenter Count	0
Covalently Bonded Unit Count	2

4 Drug and Medication Information

4.1 Drug Information

1 of 2
Drug Name	Codeine sulfate
Active Ingredient	Codeine sulfate
Dosage Form	Tablet; Solution
Route	Oral
Strength	30mg/5ml; 60mg; 30mg; 15mg
Market Status	Prescription
Company	Lannett Holdings; Roxane

2 of 2
Drug Name	Codeine sulfate
Active Ingredient	Codeine sulfate
Dosage Form	Tablet; Solution
Route	Oral
Strength	30mg/5ml; 60mg; 30mg; 15mg
Market Status	Prescription
Company	Lannett Holdings; Roxane

5 Pharmacology and Biochemistry

5.1 FDA Pharmacological Classification

5.1.1 Pharmacological Classes

Opioid Agonist [EPC]; Full Opioid Agonists [MoA]

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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET;ORAL - 15MG

USFDA APPLICATION NUMBER - 22402

DOSAGE - TABLET;ORAL - 30MG

USFDA APPLICATION NUMBER - 22402

DOSAGE - TABLET;ORAL - 60MG

USFDA APPLICATION NUMBER - 22402

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Fillers, Diluents & Binders

Direct Compression

Lubricants & Glidants

Thickeners and Stabilizers

Co-Processed Excipients

Disintegrants & Superdisintegrants

Coating Systems & Additives

Granulation

Film Formers & Plasticizers

Controlled & Modified Release

Taste Masking

Chewable & Orodispersible Aids

Emulsifying Agents

API Stability Enhancers

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US Medicaid Prescriptions

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ABOUT THIS PAGE

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Codeine Sulfate

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CHEMISTRY

Discover Molecule Insights

ACTIVE PHARMA INGREDIENTS

7 API Suppliers

3 USDMF

1 NDC API

4 Listed Suppliers

FINISHED DOSAGE FORMULATIONS

7 FDF Dossiers

7 FDA Orange Book

DRUG PRODUCT COMPOSITIONS

TABLET;ORAL - 15MG

TABLET;ORAL - 30MG

TABLET;ORAL - 60MG

RELATED EXCIPIENT COMPANIES

4 SPI Pharma

1 DKSH

2 Faran Shimi Pharmaceutical

9 Gangwal Healthcare

1 Aeon Procare

4 Anhui Sunhere Pharmaceutical Excipients Co.,Ltd

2 BASF

2 DFE Pharma

5 Gangwal Chemicals

1 Ideal Cures Pvt Ltd

2 Ingredion Pharma Solutions

4 Kerry

9 Microlex e.U

1 Pharmatrans-Sanaq

2 Pluviaendo

2 Prachin Chemical

17 Roquette

1 Seppic

3 Shanghai Shenmei Pharmaceutical Technology Co., Ltd

9 Sigachi Industries

2 Vasa Pharmachem

EXCIPIENTS BY APPLICATIONS

35 Fillers, Diluents & Binders

20 Direct Compression

16 Lubricants & Glidants

13 Thickeners and Stabilizers

11 Co-Processed Excipients

9 Disintegrants & Superdisintegrants

8 Coating Systems & Additives

7 Granulation

6 Film Formers & Plasticizers

6 Controlled & Modified Release

5 Taste Masking

5 Chewable & Orodispersible Aids

3 Emulsifying Agents

1 API Stability Enhancers

1 Topical

1 Rheology Modifiers

DIGITAL CONTENT

2 NEWS #PharmaBuzz

GLOBAL SALES INFORMATION

1 US Medicaid Prescriptions

3 Finished Drug Prices

MARKET PLACE

1 FDF Dossiers

REF. STANDARDS & IMPURITIES

1 USP

5 Others

ACTIVE PHARMA INGREDIENTS

API REF. PRICE (USD/KG)

$ 0

MARKET PLACE

0INTERMEDIATES

FINISHED DOSAGE FORMULATIONS

0 DRUGS IN DEVELOPMENT

DRUG PRODUCT COMPOSITIONS

REF. STANDARDS OR IMPURITIES

PATENTS & EXCLUSIVITIES

DIGITAL CONTENT

GLOBAL SALES INFORMATION

83 RELATED EXCIPIENT COMPANIES