| Product NDC: | 42571-119 |
| 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: | 42571-119 |
| Labeler Name: | Micro Labs Limited |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | ANDA201952 |
| Marketing Category: | ANDA |
| Start Marketing Date: | 20121215 |
| Package NDC: | 42571-119-10 |
| Package Description: | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-119-10) |
| NDC Code | 42571-119-10 |
| Proprietary Name | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
| Package Description | 1000 TABLET, FILM COATED in 1 BOTTLE (42571-119-10) |
| Product NDC | 42571-119 |
| 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 | 20121215 |
| Marketing Category Name | ANDA |
| Labeler Name | Micro Labs Limited |
| 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] |