Product NDC: | 16590-893 |
Proprietary Name: | Tramadol ER |
Non Proprietary Name: | Tramadol ER |
Active Ingredient(s): | 200 mg/1 & nbsp; Tramadol ER |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 16590-893 |
Labeler Name: | Stat Rx USA |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA078783 |
Marketing Category: | ANDA |
Start Marketing Date: | 20091027 |
Package NDC: | 16590-893-60 |
Package Description: | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-893-60) |
NDC Code | 16590-893-60 |
Proprietary Name | Tramadol ER |
Package Description | 60 TABLET, EXTENDED RELEASE in 1 BOTTLE (16590-893-60) |
Product NDC | 16590-893 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Tramadol ER |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20091027 |
Marketing Category Name | ANDA |
Labeler Name | Stat Rx USA |
Substance Name | TRAMADOL HYDROCHLORIDE |
Strength Number | 200 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |