Product NDC: | 54868-5707 |
Proprietary Name: | Suboxone |
Non Proprietary Name: | buprenorphine hydrochloride and naloxone hydrochloride |
Active Ingredient(s): | 8; 2 mg/1; mg/1 & nbsp; buprenorphine hydrochloride and naloxone hydrochloride |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 54868-5707 |
Labeler Name: | Physicians Total Care, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA020733 |
Marketing Category: | NDA |
Start Marketing Date: | 20080707 |
Package NDC: | 54868-5707-0 |
Package Description: | 30 TABLET in 1 BOTTLE (54868-5707-0) |
NDC Code | 54868-5707-0 |
Proprietary Name | Suboxone |
Package Description | 30 TABLET in 1 BOTTLE (54868-5707-0) |
Product NDC | 54868-5707 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | buprenorphine hydrochloride and naloxone hydrochloride |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20080707 |
Marketing Category Name | NDA |
Labeler Name | Physicians Total Care, Inc. |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Strength Number | 8; 2 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |