Product NDC: | 0228-3154 |
Proprietary Name: | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
Non Proprietary Name: | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
Active Ingredient(s): | 2; .5 mg/1; mg/1 & nbsp; Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0228-3154 |
Labeler Name: | Actavis Elizabeth LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA091422 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130304 |
Package NDC: | 0228-3154-09 |
Package Description: | 90 TABLET in 1 BOTTLE (0228-3154-09) |
NDC Code | 0228-3154-09 |
Proprietary Name | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
Package Description | 90 TABLET in 1 BOTTLE (0228-3154-09) |
Product NDC | 0228-3154 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Buprenorphine hydrochloride and naloxone hydrochloride dihydrate |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20130304 |
Marketing Category Name | ANDA |
Labeler Name | Actavis Elizabeth LLC |
Substance Name | BUPRENORPHINE; NALOXONE |
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] |