NDC 0143-9246

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride

Buprenorphine Hydrochloride is a Intramuscular; Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Hikma Pharmaceuticals Usa Inc.. The primary component is Buprenorphine Hydrochloride.

Product ID0143-9246_0c4e9254-1f64-45fb-acfd-2114a638262d
NDC0143-9246
Product TypeHuman Prescription Drug
Proprietary NameBuprenorphine Hydrochloride
Generic NameBuprenorphine Hydrochloride
Dosage FormInjection
Route of AdministrationINTRAMUSCULAR; INTRAVENOUS
Marketing Start Date2005-05-25
Marketing CategoryANDA / ANDA
Application NumberANDA076931
Labeler NameHikma Pharmaceuticals USA Inc.
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength0 mg/mL
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 0143-9246-05

5 VIAL in 1 CARTON (0143-9246-05) > 1 mL in 1 VIAL (0143-9246-01)
Marketing Start Date2019-07-12
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0143-9246-01 [00143924601]

Buprenorphine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA076931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2005-05-25

NDC 0143-9246-05 [00143924605]

Buprenorphine Hydrochloride INJECTION
Marketing CategoryANDA
Application NumberANDA076931
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2019-07-12

Drug Details

Active Ingredients

IngredientStrength
BUPRENORPHINE HYDROCHLORIDE.324 mg/mL

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