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Tramadol Hydrochloride and Acetaminophen
Tramadol Hydrochloride and Acetaminophen - 0378-8088-05 - (tramadol hydrochloride and acetaminophen)
Drug Information of Tramadol Hydrochloride and Acetaminophen
| 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) |
Labeler Information of Tramadol Hydrochloride and Acetaminophen
| 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 Information of Tramadol Hydrochloride and Acetaminophen
| Package NDC: | 0378-8088-05 |
| Package Description: | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-05) |
NDC Information of Tramadol Hydrochloride and Acetaminophen
| NDC Code | 0378-8088-05 |
| Proprietary Name | Tramadol Hydrochloride and Acetaminophen |
| Package Description | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0378-8088-05) |
| 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] |
