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ULTRACET
ULTRACET - 50458-650-10 - (tramadol hydrochloride and acetaminophen)
Drug Information of ULTRACET
| Product NDC: | 50458-650 |
| Proprietary Name: | ULTRACET |
| 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, COATED |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of ULTRACET
| Product NDC: | 50458-650 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA021123 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20010815 |
Package Information of ULTRACET
| Package NDC: | 50458-650-10 |
| Package Description: | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK |
NDC Information of ULTRACET
| NDC Code | 50458-650-10 |
| Proprietary Name | ULTRACET |
| Package Description | 10 BLISTER PACK in 1 BOX, UNIT-DOSE (50458-650-10) > 10 TABLET, COATED in 1 BLISTER PACK |
| Product NDC | 50458-650 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | tramadol hydrochloride and acetaminophen |
| Dosage Form Name | TABLET, COATED |
| Route Name | ORAL |
| Start Marketing Date | 20010815 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen 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] |
