Product NDC: | 0378-8088 |
Proprietary Name: | Tramadol Hydrochloride and Acetaminophen |
Non Proprietary Name: | tramadol hydrochloride and acetaminophen |
Active Ingredient(s): | 325; 37.5 mg/1; mg/1 & nbsp; tramadol hydrochloride and acetaminophen |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 0378-8088 |
Labeler Name: | Mylan Pharmaceuticals Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA077858 |
Marketing Category: | ANDA |
Start Marketing Date: | 20130529 |
Package NDC: | 0378-8088-01 |
Package Description: | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-01) |
NDC Code | 0378-8088-01 |
Proprietary Name | Tramadol Hydrochloride and Acetaminophen |
Package Description | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-01) |
Product NDC | 0378-8088 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | tramadol hydrochloride and acetaminophen |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20130529 |
Marketing Category Name | ANDA |
Labeler Name | Mylan Pharmaceuticals Inc. |
Substance Name | ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE |
Strength Number | 325; 37.5 |
Strength Unit | mg/1; mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |