FDA.reportPublic FDA data

BUPRENORPHINE

Substance profile for UNII 40D3SCR4GZ, enriched with FDA NDC listings, DailyMed labels, legacy aliases, and open chemistry identifiers.

Chemical structure for BUPRENORPHINE
Structure render from PubChem CID 644073

Substance Identity#

UNII
40D3SCR4GZ
Preferred term
BUPRENORPHINE
Registry number
52485-79-7
EC number
257-950-6
Ingredient type
INGREDIENT SUBSTANCE
Molecular formula
C29H41NO4
Chemical structure for BUPRENORPHINE
Structure render from PubChem CID 644073

Chemical And Database Identifiers#

InChIKey
RMRJXGBAOAMLHD-IHFGGWKQSA-N
SMILES
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
1819
PubChem
644073
NCIt
C61656
INN ID
3403

Open Chemistry Sources#

Source, Identifier, Link table
SourceIdentifierLink
PubChem Compound644073pubchem.ncbi.nlm.nih.gov/compound/644073
PubChem InChIKey SearchRMRJXGBAOAMLHD-IHFGGWKQSA-Npubchem.ncbi.nlm.nih.gov/#query=RMRJXGBAOAMLHD-IHFGGWKQSA-N
RxNorm1819mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=1819
NCI ThesaurusC61656ncit.nci.nih.gov/ncitbrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C61656
FDA Substance Registration System40D3SCR4GZprecision.fda.gov/uniisearch/srs/unii/40D3SCR4GZ
European Community number257-950-6commonchemistry.cas.org/results?q=257-950-6

DailyMed Socrata Ingredients#

Type, DailyMed label, SPL version table
TypeDailyMed labelSPL version
ACTIVE MOIETY7fc0c3fd-5122-43ce-995d-a55a7ea023713
ACTIVE MOIETYc385095b-152a-45fd-8c49-3e44493e9a002
ACTIVE MOIETY8081ccb8-1b38-4673-a9dd-0fb18fa6038a1
ACTIVE MOIETYAnimalgesics for Mice & Rats2
ACTIVE MOIETYAnimalgesics for Mice & Rats1
ACTIVE MOIETYAnimalgesics for Mice1
ACTIVE MOIETYThese 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
ACTIVE MOIETYBuprenorphine Hydrochloride Injection1
ACTIVE MOIETY97677ce7-9562-43d0-8b99-8d1f37c1e3c61
ACTIVE MOIETYBuprenorphine hydrochloride 8mg1002
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) TABLET [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3832
ACTIVE MOIETYBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3761
ACTIVE INGREDIENTBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [LAKE ERIE MEDICAL & SURGICAL SUPPLY DBA QUALITY CARE PRODUCTS LLC]3761
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET [BRYANT RANCH PREPACK]1004
ACTIVE MOIETYBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [BRYANT RANCH PREPACK]1000
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE (BUPRENORPHINE HYDROCHLORIDE) TABLET [REMEDYREPACK INC. ]130
ACTIVE INGREDIENTBUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]130
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]130
ACTIVE MOIETYBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AMNEAL PHARMACEUTICALS OF NEW YORK, LLC]15
ACTIVE MOIETYBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
ACTIVE INGREDIENTBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [PURDUE PHARMA LP]15
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [HOSPIRA, INC.]10
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [HI-TECH PHARMACAL CO., INC.]10
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [INDIVIOR INC.]9
ACTIVE MOIETYBUPRENORPHINE AND NALOXONE (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE) TABLET [ACTAVIS PHARMA, INC.]8
ACTIVE MOIETYBUPRENORPHINE HCL TABLET [ROXANE LABORATORIES, INC]8
ACTIVE MOIETYBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]5
ACTIVE INGREDIENTBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [AVKARE, INC.]5
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [TEVA PHARMACEUTICALS USA INC]5
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) TABLET [PD-RX PHARMACEUTICALS, INC.]5
ACTIVE MOIETYZUBSOLV (BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE) TABLET, ORALLY DISINTEGRATING [OREXO US, INC.]5
ACTIVE MOIETYBUPRENORPHINE AND NALOXONE TABLET [TEVA PHARMACEUTICALS USA INC]4
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE SUBLINGUAL TABLET [MYLAN PHARMACEUTICALS INC.]4
ACTIVE MOIETYSIMBADOL (BUPRENORPHINE) INJECTION [ABBOTT LABORATORIES]4
ACTIVE MOIETYBELBUCA (BUPRENORPHINE HYDROCHLORIDE) FILM [ENDO PHARMACEUTICALS]3
ACTIVE MOIETYBUNAVAIL (BUPRENORPHINE AND NALOXONE) FILM [BIODELIVERY SCIENCES INTERNATIONAL, INC.]3
ACTIVE MOIETYBUPRENEX (BUPRENORPHINE HYDROCHLORIDE) INJECTION [RECKITT BENCKISER PHARMACEUTICALS INC]3
ACTIVE MOIETYBUPRENORPHINE (BUPRENORPHINE HYDROCHLORIDE) TABLET [ACTAVIS PHARMA, INC.]3
ACTIVE MOIETYBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [MALLINCKRODT, INC.]3
ACTIVE MOIETYBUPRENORPHINE HCL TABLET [CARDINAL HEALTH]2
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE DIHYDRATE TABLET [ROXANE LABORATORIES, INC.]2
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE INJECTION [PAR PHARMACEUTICAL INC.]2
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]2
ACTIVE MOIETYBUPRENORPHINE HCL AND NALOXONE HCL (BUPRENORPHINE AND NALOXONE) TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE INJECTION, SOLUTION [AMERICAN REGENT, INC.]1
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [A-S MEDICATION SOLUTIONS LLC]1
ACTIVE MOIETYBUPRENORPHINE HYDROCHLORIDE TABLET [REMEDYREPACK INC. ]1
ACTIVE MOIETYBUPRENORPHINE SOLUTION [PAYLESS COMPOUNDERS, LLC]1
ACTIVE INGREDIENTBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
ACTIVE MOIETYBUTRANS (BUPRENORPHINE) PATCH, EXTENDED RELEASE [A-S MEDICATION SOLUTIONS LLC]1
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [A-S MEDICATION SOLUTIONS LLC]1
ACTIVE MOIETYSUBOXONE (BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE) FILM, SOLUBLE [LAKE ERIE MEDICAL DBA QUALITY CARE PRODUCTS LLC]1