NDC 67046-999

Buprenorphine HCl

Buprenorphine Hcl

Buprenorphine HCl is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Contract Pharmacy Services-pa. The primary component is Buprenorphine Hydrochloride.

Product ID67046-999_593c9ffe-e96e-d873-e053-2a91aa0a0e19
NDC67046-999
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 NameContract Pharmacy Services-PA
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 67046-999-30

30 TABLET in 1 BLISTER PACK (67046-999-30)
Marketing Start Date2017-09-15
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67046-999-30 [67046099930]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-09-15
Marketing End Date2018-09-11

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:593c9ffe-e96d-d873-e053-2a91aa0a0e19
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 351264
    • UPC Code
  • 0300540176136
  • 0300540177133

    • Pharmacological Class

    • 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
    © 2024 FDA.report
    This site is not affiliated with or endorsed by the FDA.