NDC 58118-0501

BUPRENORPHINE

Buprenorphine

BUPRENORPHINE is a Sublingual Tablet in the Human Prescription Drug category. It is labeled and distributed by Clinical Solutions Wholesale, Llc. The primary component is Buprenorphine Hydrochloride.

Product ID58118-0501_e64da5c5-a980-2590-e053-2995a90aa955
NDC58118-0501
Product TypeHuman Prescription Drug
Proprietary NameBUPRENORPHINE
Generic NameBuprenorphine
Dosage FormTablet
Route of AdministrationSUBLINGUAL
Marketing Start Date2017-10-25
Marketing CategoryANDA /
Application NumberANDA207276
Labeler NameClinical Solutions Wholesale, LLC
Substance NameBUPRENORPHINE HYDROCHLORIDE
Active Ingredient Strength2 mg/1
Pharm ClassesPartial Opioid Agonist [EPC], Partial Opioid Agonists [MoA]
DEA ScheduleCIII
NDC Exclude FlagN
Listing Certified Through2023-12-31

Packaging

NDC 58118-0501-8

30 TABLET in 1 BLISTER PACK (58118-0501-8)
Marketing Start Date2017-10-25
NDC Exclude FlagN
Sample Package?N

Drug Details

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

NDCBrand NameGeneric Name
0093-3239BuprenorphineBuprenorphine
0093-3600BuprenorphineBuprenorphine
0093-3601BuprenorphineBuprenorphine
0093-3602BuprenorphineBuprenorphine
0093-3603BuprenorphineBuprenorphine
0093-3656BuprenorphineBuprenorphine
0093-3657BuprenorphineBuprenorphine
0093-3658BuprenorphineBuprenorphine
0093-3659BuprenorphineBuprenorphine
0228-3153BuprenorphineBuprenorphine
0228-3156BuprenorphineBuprenorphine
70518-0711BuprenorphineBuprenorphine
70518-1557BuprenorphineBuprenorphine
70518-1625BuprenorphineBuprenorphine
71335-0353BuprenorphineBuprenorphine
71335-0950BUPRENORPHINEBUPRENORPHINE
42858-586BuprenorphineBuprenorphine
42858-750BuprenorphineBuprenorphine
42858-502BUPRENORPHINEBUPRENORPHINE
42858-501BUPRENORPHINEBUPRENORPHINE
42858-353BuprenorphineBuprenorphine
42858-839BuprenorphineBuprenorphine
42858-493BuprenorphineBuprenorphine
50090-2924BuprenorphineBuprenorphine
55700-579BuprenorphineBuprenorphine
55700-568BuprenorphineBuprenorphine
58118-3156BuprenorphineBuprenorphine
62756-459BuprenorphineBuprenorphine
62756-460BuprenorphineBuprenorphine
67046-994BuprenorphineBuprenorphine
67046-995BuprenorphineBuprenorphine
71335-1154BUPRENORPHINEBUPRENORPHINE
70518-2218BUPRENORPHINEBUPRENORPHINE
70518-2217BUPRENORPHINEBUPRENORPHINE

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