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Buprenorphine Hydrochloride - 0517-0725-05 - (Buprenorphine Hydrochloride)

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Drug Information of Buprenorphine Hydrochloride

Product NDC: 0517-0725
Proprietary Name: Buprenorphine Hydrochloride
Non Proprietary Name: Buprenorphine Hydrochloride
Active Ingredient(s): .324    mg/mL & nbsp;   Buprenorphine Hydrochloride
Administration Route(s): INTRAMUSCULAR; INTRAVENOUS
Dosage Form(s): INJECTION, SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of Buprenorphine Hydrochloride

Product NDC: 0517-0725
Labeler Name: American Regent, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA078331
Marketing Category: ANDA
Start Marketing Date: 20100813

Package Information of Buprenorphine Hydrochloride

Package NDC: 0517-0725-05
Package Description: 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01)

NDC Information of Buprenorphine Hydrochloride

NDC Code 0517-0725-05
Proprietary Name Buprenorphine Hydrochloride
Package Description 5 VIAL in 1 CARTON (0517-0725-05) > 1 mL in 1 VIAL (0517-0725-01)
Product NDC 0517-0725
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Buprenorphine Hydrochloride
Dosage Form Name INJECTION, SOLUTION
Route Name INTRAMUSCULAR; INTRAVENOUS
Start Marketing Date 20100813
Marketing Category Name ANDA
Labeler Name American Regent, Inc.
Substance Name BUPRENORPHINE HYDROCHLORIDE
Strength Number .324
Strength Unit mg/mL
Pharmaceutical Classes Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA]

Complete Information of Buprenorphine Hydrochloride


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