FDA.reportPublic FDA data

BUPRENORPHINE HYDROCHLORIDE

Substance profile for UNII 56W8MW3EN1, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for BUPRENORPHINE HYDROCHLORIDE
Structure render from PubChem CID 3033050

Substance Identity#

UNII
56W8MW3EN1
Preferred term
BUPRENORPHINE HYDROCHLORIDE
Registry number
53152-21-9
EC number
258-396-8
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C29H41NO4.ClH
Chemical structure for BUPRENORPHINE HYDROCHLORIDE
Structure render from PubChem CID 3033050

Chemical And Database Identifiers#

InChIKey
UAIXRPCCYXNJMQ-RZIPZOSSSA-N
SMILES
Cl.CO[C@]12CC[C@@]3(C[C@@H]1[C@](C)(O)C(C)(C)C)[C@H]4CC5=C6C(O[C@@H]2[C@@]36CCN4CC7CC7)=C(O)C=C5
RxCUI
203841
PubChem
3033050
NCIt
C47424
INN ID
0

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound3033050pubchem.ncbi.nlm.nih.gov/compound/3033050
PubChem InChIKey SearchUAIXRPCCYXNJMQ-RZIPZOSSSA-Npubchem.ncbi.nlm.nih.gov/#query=UAIXRPCCYXNJMQ-RZIPZOSSSA-N
RxNorm203841mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=203841
NCI ThesaurusC47424ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C47424
FDA Substance Registration System56W8MW3EN1precision.fda.gov/uniisearch/srs/unii/56W8MW3EN1
European Community number258-396-8commonchemistry.cas.org/results?q=258-396-8

DailyMed Socrata Ingredients#

DailyMed label, SPL version table
DailyMed labelSPL version
7fc0c3fd-5122-43ce-995d-a55a7ea023713
c385095b-152a-45fd-8c49-3e44493e9a002
8081ccb8-1b38-4673-a9dd-0fb18fa6038a1
Animalgesics for Mice & Rats2
Animalgesics for Mice & Rats1
Animalgesics for Mice1
These highlights do not include all the information needed to use SUBOXONE sublingual film safely and effectively. See full prescribing information for SUBOXONE sublingual film. SUBOXONE (buprenorphine and naloxone) sublingual film for sublingual administration CIII Initial U.S. Approval: 20022
Buprenorphine Hydrochloride Injection1
97677ce7-9562-43d0-8b99-8d1f37c1e3c61
Buprenorphine hydrochloride 8mg1002
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3832
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1004
BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
BUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC. ]130
BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
BUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.]10
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
BUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.]8
BUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
BUPRENORPHINE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]5
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
ZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
BUPRENORPHINE AND NALOXONE TABLET [TEVA PHARMACEUTICALS USA INC]4
BUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLET [MYLAN PHARMACEUTICALS INC.]4
SIMBADOL (BUPRENORPHINE) INJECTION [ABBOTT LABORATORIES]4
BELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM [ENDO PHARMACEUTICALS]3
BUNAVAIL (BUPRENORPHINE AND NALOXONE) FILM [BIODELIVERY SCIENCES INTERNATIONAL, INC.]3
BUPRENEX (BUPRENORPHINE HYDROCHLORIDE) INJECTION [RECKITT BENCKISER PHARMACEUTICALS INC]3
BUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.]3
BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]3
BUPRENORPHINE HCL TABLET [CARDINAL HEALTH]2
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
BUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]2
BUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]2
BUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
BUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
BUPRENORPHINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
BUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]1
BUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [A-S MEDICATION SOLUTIONS LLC]1
SUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1