NDC 16729-550

BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE

Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate

BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Accord Healthcare, Inc. The primary component is Buprenorphine Hydrochloride; Naloxone Hydrochloride Dihydrate.

Product ID16729-550_b9cf63dd-8f72-57a7-e053-2a95a90af659
NDC16729-550
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
Generic NameBuprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2021-01-22
Marketing CategoryANDA / ANDA
Application NumberANDA209069
Labeler NameAccord Healthcare, Inc
Substance NameBUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE DIHYDRATE
Active Ingredient Strength8 mg/1; mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC],Opioid Antagonist [EPC],Opioid Antagonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2022-12-31

Packaging

NDC 16729-550-10

30 TABLET in 1 BOTTLE, PLASTIC (16729-550-10)
Marketing Start Date2021-01-22
NDC Exclude FlagN
Sample Package?N

Drug Details

NDC Crossover Matching brand name "BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE" or generic name "Buprenorphine Hydrochloride And Naloxone Hydrochloride Dihydrate"

NDCBrand NameGeneric Name
0054-0188buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
0054-0189buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
0406-8005Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0406-8020Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
0904-7009buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
0904-7010buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
16729-549BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
16729-550BUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATEBUPRENORPHINE HYDROCHLORIDE and NALOXONE HYDROCHLORIDE DIHYDRATE
71335-1653buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
71335-1725Buprenorphine Hydrochloride and Naloxone Hydrochloride DihydrateBuprenorphine Hydrochloride and Naloxone Hydrochloride Dihydrate
71335-1720buprenorphine hydrochloride and naloxone hydrochloride dihydratebuprenorphine hydrochloride and naloxone hydrochloride dihydrate
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