NDC 70518-2014

Buprenorphine HCl

Buprenorphine Hcl

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

Product ID70518-2014_865b4812-11e8-8ee8-e053-2a91aa0ad4c5
NDC70518-2014
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine HCl
Generic NameBuprenorphine Hcl
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2019-04-12
Marketing CategoryANDA / ANDA
Application NumberANDA078633
Labeler NameREMEDYREPACK INC.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-2014-0

30 TABLET in 1 BLISTER PACK (70518-2014-0)
Marketing Start Date2019-04-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-2014-0 [70518201400]

Buprenorphine HCl TABLET
Marketing CategoryANDA
Application NumberANDA078633
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2019-04-12

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:69a647c0-bc09-4ee2-aeb3-ef286caf25e5
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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