NDC 70518-0652

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 Remedyrepack Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID70518-0652_7faed134-216b-7c41-e053-2a91aa0a1dfe
NDC70518-0652
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride Sublingual
Generic NameBuprenorphine Hydrochloride Sublingual
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2017-07-31
Marketing CategoryANDA / ANDA
Application NumberANDA201066
Labeler NameREMEDYREPACK INC.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 70518-0652-0

60 TABLET in 1 BOTTLE, PLASTIC (70518-0652-0)
Marketing Start Date2017-07-31
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 70518-0652-1 [70518065201]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-12-08
Marketing End Date2020-04-30

NDC 70518-0652-2 [70518065202]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2018-03-16
Marketing End Date2020-04-30

NDC 70518-0652-0 [70518065200]

Buprenorphine Hydrochloride Sublingual TABLET
Marketing CategoryANDA
Application NumberANDA201066
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2017-07-31
Marketing End Date2020-04-30

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE2 mg/1

OpenFDA Data

SPL SET ID:0f2b837a-8e5d-4e7f-9f18-763efae73f97
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 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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