NDC 0517-0725

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride is a Intramuscular; Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by American Regent, Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID0517-0725_832fae8e-0310-4981-8cf0-86d2c9523c2e
NDC0517-0725
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride
Generic NameBuprenorphine Hydrochloride
Dosage FormInjection, Solution
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2010-08-13
Marketing CategoryANDA / ANDA
Application NumberANDA078331
Labeler NameAmerican Regent, Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesPartial Opioid Agonists [MoA],Partial Opioid Agonist [EPC]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 0517-0725-05

5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01)
Marketing Start Date2010-08-13
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0517-0725-05 [00517072505]

Buprenorphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-13

NDC 0517-0725-01 [00517072501]

Buprenorphine Hydrochloride INJECTION, SOLUTION
Marketing CategoryANDA
Application NumberANDA078331
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2010-08-13

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.324 mg/mL

OpenFDA Data

SPL SET ID:249ac38b-84ae-4cd2-a8d1-fc84212360ac
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 238129

    • Pharmacological Class

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

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

    NDCBrand NameGeneric Name
    0143-9246Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0409-2012Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    0517-0725Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    21695-515Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    35356-556buprenorphine hydrochloridebuprenorphine hydrochloride
    42023-179Buprenorphine HydrochlorideBuprenorphine Hydrochloride
    50090-1571buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-924buprenorphine hydrochloridebuprenorphine hydrochloride
    50383-930buprenorphine hydrochloridebuprenorphine hydrochloride
    53217-246buprenorphine hydrochloridebuprenorphine hydrochloride
    70518-0442buprenorphine hydrochloridebuprenorphine hydrochloride
    63629-4092Buprenorphine hydrochlorideBuprenorphine hydrochloride
    63629-7126buprenorphine hydrochloridebuprenorphine hydrochloride
    64725-1924buprenorphine hydrochloridebuprenorphine hydrochloride
    64725-0930buprenorphine hydrochloridebuprenorphine hydrochloride
    67046-991buprenorphine hydrochloridebuprenorphine hydrochloride
    67046-990buprenorphine hydrochloridebuprenorphine hydrochloride
    70518-2216buprenorphine hydrochloridebuprenorphine hydrochloride
    55700-867BELBUCAbuprenorphine hydrochloride
    12496-0757Buprenexbuprenorphine hydrochloride
    50090-2924BuprenorphineBuprenorphine Hydrochloride
    52440-100Probuphinebuprenorphine hydrochloride
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