Product NDC: | 50383-930 |
Proprietary Name: | buprenorphine hydrochloride |
Non Proprietary Name: | buprenorphine hydrochloride |
Active Ingredient(s): | 8 mg/1 & nbsp; buprenorphine hydrochloride |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 50383-930 |
Labeler Name: | Hi-Tech Pharmacal Co., Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA090622 |
Marketing Category: | ANDA |
Start Marketing Date: | 20100924 |
Package NDC: | 50383-930-93 |
Package Description: | 30 TABLET in 1 BOTTLE (50383-930-93) |
NDC Code | 50383-930-93 |
Proprietary Name | buprenorphine hydrochloride |
Package Description | 30 TABLET in 1 BOTTLE (50383-930-93) |
Product NDC | 50383-930 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | buprenorphine hydrochloride |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20100924 |
Marketing Category Name | ANDA |
Labeler Name | Hi-Tech Pharmacal Co., Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE |
Strength Number | 8 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA] |