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1. 6029 M
2. 6029-m
3. 6029m
4. Buprenex
5. Buprenorphine
6. Buprenorphine Hydrochloride
7. Buprex
8. Hydrochloride, Buprenorphine
9. Prefin
10. Rx 6029 M
11. Rx-6029-m
12. Rx6029m
13. Subutex
14. Temgsic
15. Temgesic
1. Buprenorphine Hydrochloride
2. Ncgc00247733-01
3. Dsstox_cid_28831
4. Dsstox_rid_83100
5. Dsstox_gsid_48905
6. Tox21_112899
7. Cas-53152-21-9
| Molecular Weight | 504.1 g/mol |
|---|---|
| Molecular Formula | C29H42ClNO4 |
| Hydrogen Bond Donor Count | 3 |
| Hydrogen Bond Acceptor Count | 5 |
| Rotatable Bond Count | 5 |
| Exact Mass | 503.2802365 g/mol |
| Monoisotopic Mass | 503.2802365 g/mol |
| Topological Polar Surface Area | 62.2 Ų |
| Heavy Atom Count | 35 |
| Formal Charge | 0 |
| Complexity | 869 |
| Isotope Atom Count | 0 |
| Defined Atom Stereocenter Count | 6 |
| Undefined Atom Stereocenter Count | 1 |
| Defined Bond Stereocenter Count | 0 |
| Undefined Bond Stereocenter Count | 0 |
| Covalently Bonded Unit Count | 2 |
| 1 of 2 | |
|---|---|
| Drug Name | Buprenorphine hydrochloride |
| Drug Label | Buprenorphine hydrochloride sublingual tablets contains buprenorphine HCl.Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Buprenorphine is a Schedule III narcotic under the Controlled Subst... |
| Active Ingredient | Buprenorphine hydrochloride |
| Dosage Form | Injectable; Tablet |
| Route | Sublingual; Injection |
| Strength | eq 2mg base; eq 0.3mg base/ml; eq 8mg base |
| Market Status | Prescription |
| Company | Hospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr |
| 2 of 2 | |
|---|---|
| Drug Name | Buprenorphine hydrochloride |
| Drug Label | Buprenorphine hydrochloride sublingual tablets contains buprenorphine HCl.Buprenorphine is a partial agonist at the mu-opioid receptor and an antagonist at the kappa-opioid receptor. Buprenorphine is a Schedule III narcotic under the Controlled Subst... |
| Active Ingredient | Buprenorphine hydrochloride |
| Dosage Form | Injectable; Tablet |
| Route | Sublingual; Injection |
| Strength | eq 2mg base; eq 0.3mg base/ml; eq 8mg base |
| Market Status | Prescription |
| Company | Hospira; Ethypharm; Luitpold; Eurohlth Intl; Roxane; Barr |
Sixmo is indicated for substitution treatment for opioid dependence in clinically stable adult patients who require no more than 8 mg/day of sublingual buprenorphine, within a framework of medical, social and psychological treatment.
Treatment of opioid dependence
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.)
Narcotic Antagonists
Agents inhibiting the effect of narcotics on the central nervous system. (See all compounds classified as Narcotic Antagonists.)
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.)
N07BC01
API SUPPLIERS
Temad- We think of world-class quality.
Date of Issue : 2018-01-09
Valid Till : 2019-01-09
Written Confirmation Number : 665/131411
Address of the Firm :
Faran Shimi: Leading producer of high-quality APIs & alkaloid opiates, serving major pharmaceutical companies across the Middle East.
Noramco is a partner to the pharmaceutical industry for controlled substance development & manufacturing.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-11-23
Pay. Date : 2012-11-23
DMF Number : 23683
Submission : 2010-04-05
Status : Active
Type : II
Certificate Number : R1-CEP 2010-142 - Rev 05
Issue Date : 2023-08-23
Type : Chemical
Substance Number : 1181
Status : Valid
NDC Package Code : 51634-0608
Start Marketing Date : 2017-07-26
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1kg/kg)
Marketing Category : BULK INGREDIENT
SCI Pharmtech offers high-quality, cost-effective APIs, advanced intermediates, & custom products with global expertise and precision.
EUROAPI, the leading small molecules API player, provides both API sales & CDMO services.
Sanofi is a pioneer in Diabetes Solutions, Human Vaccines, Innovative Drugs, Consumer Healthcare, and the new Genzyme.
Certificate Number : R1-CEP 2010-291 - Rev 00
Issue Date : 2016-04-11
Type : Chemical
Substance Number : 1181
Status : Withdrawn by Holder
Veranova: A CDMO that manages complexity with confidence.
GDUFA
DMF Review : Reviewed
Rev. Date : 2012-12-26
Pay. Date : 2012-11-30
DMF Number : 19109
Submission : 2006-01-12
Status : Active
Type : II
Certificate Number : R1-CEP 2002-168 - Rev 07
Issue Date : 2019-09-25
Type : Chemical
Substance Number : 1181
Status : Valid
Registration Number : 218MF11027
Registrant's Address : 10 Wheatfield Road, Edinburgh EH11 2QA, United Kingdom
Initial Date of Registration : 2006-12-28
Latest Date of Registration : --
NDC Package Code : 12707-035
Start Marketing Date : 2017-12-14
End Marketing Date : 2024-12-31
Dosage Form (Strength) : POWDER (1g/g)
Marketing Category : BULK INGREDIENT
| Available Reg Filing : ROW |
Aspen API. More than just an API.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 7099
Submission : 1987-08-06
Status : Active
Type : II
Rusan Pharma: Over 30 years of specializing in the treatment of Addiction and Pain Management.
Certificate Number : R1-CEP 2017-228 - Rev 00
Issue Date : 2023-01-23
Type : Chemical
Substance Number : 1181
Status : Valid
Date of Issue : 2021-08-27
Valid Till : 2024-06-10
Written Confirmation Number : WC-0278
Address of the Firm :
Parand Darou is a knowledge-based company, focused on the production of Narcotic APIs.
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DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE...DOSAGE - INJECTABLE;INJECTION - EQ 0.3MG BASE/ML **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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USFDA APPLICATION NUMBER - 20733
DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2...DOSAGE - TABLET;SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
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USFDA APPLICATION NUMBER - 207932
DOSAGE - FILM;BUCCAL - EQ 0.45MG BASE
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USFDA APPLICATION NUMBER - 22410
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DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BAS...DOSAGE - FILM;BUCCAL, SUBLINGUAL - EQ 8MG BASE;EQ 2MG BASE
USFDA APPLICATION NUMBER - 22410
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