NDC 0378-0923

Buprenorphine Hydrochloride Sublingual

Buprenorphine Hydrochloride Sublingual

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

Product ID0378-0923_140de61a-37dc-465e-a4c6-35b605b918a8
NDC0378-0923
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride Sublingual
Generic NameBuprenorphine Hydrochloride Sublingual
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2015-03-06
Marketing End Date2019-10-31
Marketing CategoryANDA / ANDA
Application NumberANDA201066
Labeler NameMylan Pharmaceuticals Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN

Packaging

NDC 0378-0923-93

30 TABLET in 1 BOTTLE, PLASTIC (0378-0923-93)
Marketing Start Date2015-03-06
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0378-0923-93 [00378092393]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2015-03-06
Marketing End Date2019-10-31

NDC 0378-0923-77 [00378092377]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-06
Marketing End Date2016-04-15

NDC 0378-0923-05 [00378092305]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2015-03-06
Marketing End Date2016-04-15

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:7a85f424-9d83-49d9-8a17-478abce6fddd
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 351265
  • 351264
  • Pharmacological Class

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

    NDC Crossover Matching brand name "Buprenorphine Hydrochloride Sublingual" or generic name "Buprenorphine Hydrochloride Sublingual"

    NDCBrand NameGeneric Name
    0378-0923Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingual
    0378-0924Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingual
    67046-996Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingual
    67046-997Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingual
    70518-0652Buprenorphine Hydrochloride Sublingualbuprenorphine hydrochloride sublingual

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