Product NDC: | 12496-1202 |
Proprietary Name: | Suboxone |
Non Proprietary Name: | buprenorphine hydrochloride, naloxone hydrochloride |
Active Ingredient(s): | 2; .5 mg/1; mg/1 & nbsp; buprenorphine hydrochloride, naloxone hydrochloride |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | FILM, SOLUBLE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 12496-1202 |
Labeler Name: | Reckitt Benckiser Pharmaceuticals Inc |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022410 |
Marketing Category: | NDA |
Start Marketing Date: | 20100913 |
Package NDC: | 12496-1202-3 |
Package Description: | 30 POUCH in 1 CARTON (12496-1202-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) |
NDC Code | 12496-1202-3 |
Proprietary Name | Suboxone |
Package Description | 30 POUCH in 1 CARTON (12496-1202-3) > 1 FILM, SOLUBLE in 1 POUCH (12496-1202-1) |
Product NDC | 12496-1202 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | buprenorphine hydrochloride, naloxone hydrochloride |
Dosage Form Name | FILM, SOLUBLE |
Route Name | SUBLINGUAL |
Start Marketing Date | 20100913 |
Marketing Category Name | NDA |
Labeler Name | Reckitt Benckiser Pharmaceuticals Inc |
Substance Name | BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE |
Strength Number | 2; .5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Partial Opioid Agonist [EPC],Partial Opioid Agonists [MoA],Opioid Antagonist [EPC],Opioid Antagonists [MoA] |