| Product NDC: | 50458-659 |
| Proprietary Name: | ULTRAM |
| Non Proprietary Name: | tramadol hydrochloride |
| Active Ingredient(s): | 50 mg/1 & nbsp; tramadol hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, COATED |
| Coding System: | National Drug Codes(NDC) |
| Product NDC: | 50458-659 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA020281 |
| Marketing Category: | NDA |
| Start Marketing Date: | 19950303 |
| Package NDC: | 50458-659-60 |
| Package Description: | 100 TABLET, COATED in 1 BOTTLE (50458-659-60) |
| NDC Code | 50458-659-60 |
| Proprietary Name | ULTRAM |
| Package Description | 100 TABLET, COATED in 1 BOTTLE (50458-659-60) |
| Product NDC | 50458-659 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | tramadol hydrochloride |
| Dosage Form Name | TABLET, COATED |
| Route Name | ORAL |
| Start Marketing Date | 19950303 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | TRAMADOL HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |