NDC 71335-1163

Buprenorphine HCl

Buprenorphine Hcl

Buprenorphine HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Bryant Ranch Prepack. The primary component is Buprenorphine Hydrochloride.

Product ID71335-1163_24bf44b3-4d26-4cb6-9078-5ad6613fd615
NDC71335-1163
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl
Generic NameBuprenorphine Hcl
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2009-10-08
Marketing CategoryANDA / ANDA
Application NumberANDA078633
Labeler NameBryant Ranch Prepack
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 71335-1163-0

120 TABLET in 1 BOTTLE (71335-1163-0)
Marketing Start Date2022-09-16
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 71335-1163-3 [71335116303]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-4 [71335116304]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-7 [71335116307]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-5 [71335116305]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-2 [71335116302]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-9 [71335116309]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-8 [71335116308]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-1 [71335116301]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

NDC 71335-1163-6 [71335116306]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-01

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:d5a8c41e-413e-4d48-9739-d158e5681dd0
Manufacturer
UNII

Pharmacological Class

  • Partial Opioid Agonists [MoA]
  • Partial Opioid Agonist [EPC]
  • Partial Opioid Agonists [MoA]
  • Partial Opioid Agonist [EPC]

NDC Crossover Matching brand name "Buprenorphine HCl" or generic name "Buprenorphine Hcl"

NDCBrand NameGeneric Name
0054-0176Buprenorphine HClBuprenorphine HCl
0054-0177Buprenorphine HClBuprenorphine HCl
0904-7154Buprenorphine HClBuprenorphine HCl
0904-7155Buprenorphine HClBuprenorphine HCl
55700-302Buprenorphine HClBuprenorphine HCl
55700-303Buprenorphine HClBuprenorphine HCl
58118-0176Buprenorphine HClBuprenorphine HCl
58118-0177Buprenorphine HClBuprenorphine HCl
67046-998Buprenorphine HClBuprenorphine HCl
67046-999Buprenorphine HClBuprenorphine HCl
70518-2014Buprenorphine HClBuprenorphine HCl
70518-2226Buprenorphine HClBuprenorphine HCl
71335-1163Buprenorphine HClBuprenorphine HCl
76519-1170BUPRENORPHINE HCLBUPRENORPHINE HCL
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