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Buprenorphine and Naloxone

NDC 0121-1018 · HUMAN PRESCRIPTION DRUG · TABLET

Generic namebuprenorphine hydrochloride and naloxone hydrochloride
Labeler / ManufacturerPAI Holdings, LLC dba Pharmaceutical Associates, Inc. and dba PAI Pharma
Marketing categoryAbbreviated NDA (generic) · App ANDA204431
Dosage form / routeTABLET · SUBLINGUAL
Active ingredientsBUPRENORPHINE HYDROCHLORIDE (2 mg/1)
NALOXONE HYDROCHLORIDE (.5 mg/1)
Marketing started20230905
Package count1

External sources

Source: openFDA. Public-domain (CC0).