Product NDC: | 16590-889 |
Proprietary Name: | NUCYNTA |
Non Proprietary Name: | TAPENTADOL HYDROCHLORIDE |
Active Ingredient(s): | 75 mg/1 & nbsp; TAPENTADOL HYDROCHLORIDE |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-889 |
Labeler Name: | STAT RX USA LLC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA022304 |
Marketing Category: | NDA |
Start Marketing Date: | 20090601 |
Package NDC: | 16590-889-60 |
Package Description: | 60 TABLET, FILM COATED in 1 BOTTLE (16590-889-60) |
NDC Code | 16590-889-60 |
Proprietary Name | NUCYNTA |
Package Description | 60 TABLET, FILM COATED in 1 BOTTLE (16590-889-60) |
Product NDC | 16590-889 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | TAPENTADOL HYDROCHLORIDE |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20090601 |
Marketing Category Name | NDA |
Labeler Name | STAT RX USA LLC |
Substance Name | TAPENTADOL HYDROCHLORIDE |
Strength Number | 75 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Opioid Agonist [EPC],Opioid Agonists [MoA] |