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NUCYNTA
NUCYNTA - 50458-860-01 - (tapentadol hydrochloride)
Drug Information of NUCYNTA
| Product NDC: | 50458-860 |
| Proprietary Name: | NUCYNTA |
| Non Proprietary Name: | tapentadol hydrochloride |
| Active Ingredient(s): | 50 mg/1 & nbsp; tapentadol hydrochloride |
| Administration Route(s): | ORAL |
| Dosage Form(s): | TABLET, FILM COATED, EXTENDED RELEASE |
| Coding System: | National Drug Codes(NDC) |
Labeler Information of NUCYNTA
| Product NDC: | 50458-860 |
| Labeler Name: | Janssen Pharmaceuticals, Inc. |
| Product Type: | HUMAN PRESCRIPTION DRUG |
| FDA Application Number: | NDA200533 |
| Marketing Category: | NDA |
| Start Marketing Date: | 20110825 |
Package Information of NUCYNTA
| Package NDC: | 50458-860-01 |
| Package Description: | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-860-01) |
NDC Information of NUCYNTA
| NDC Code | 50458-860-01 |
| Proprietary Name | NUCYNTA |
| Package Description | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (50458-860-01) |
| Product NDC | 50458-860 |
| Product Type Name | HUMAN PRESCRIPTION DRUG |
| Non Proprietary Name | tapentadol hydrochloride |
| Dosage Form Name | TABLET, FILM COATED, EXTENDED RELEASE |
| Route Name | ORAL |
| Start Marketing Date | 20110825 |
| Marketing Category Name | NDA |
| Labeler Name | Janssen Pharmaceuticals, Inc. |
| Substance Name | TAPENTADOL HYDROCHLORIDE |
| Strength Number | 50 |
| Strength Unit | mg/1 |
| Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |
