Product NDC: | 42291-175 |
Proprietary Name: | Buprenorphine HCl and Naloxone HCl |
Non Proprietary Name: | Buprenorphine and Naloxone |
Active Ingredient(s): | 8; 2 mg/1; mg/1 & nbsp; Buprenorphine and Naloxone |
Administration Route(s): | SUBLINGUAL |
Dosage Form(s): | TABLET |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42291-175 |
Labeler Name: | AvKARE, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA203136 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130401 |
Package NDC: | 42291-175-30 |
Package Description: | 30 TABLET in 1 BOTTLE (42291-175-30) |
NDC Code | 42291-175-30 |
Proprietary Name | Buprenorphine HCl and Naloxone HCl |
Package Description | 30 TABLET in 1 BOTTLE (42291-175-30) |
Product NDC | 42291-175 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Buprenorphine and Naloxone |
Dosage Form Name | TABLET |
Route Name | SUBLINGUAL |
Start Marketing Date | 20130401 |
Marketing Category Name | ANDA |
Labeler Name | AvKARE, Inc. |
Substance Name | BUPRENORPHINE; NALOXONE |
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] |