Product NDC: | 68180-383 |
Proprietary Name: | Tramadol Hydrochloride |
Non Proprietary Name: | Tramadol Hydrochloride |
Active Ingredient(s): | 100 mg/1 & nbsp; Tramadol Hydrochloride |
Administration Route(s): | ORAL |
Dosage Form(s): | TABLET, EXTENDED RELEASE |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 68180-383 |
Labeler Name: | LUPIN PHARMACEUTICALS INC |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA200503 |
Marketing Category: | ANDA |
Start Marketing Date: | 20110826 |
Package NDC: | 68180-383-02 |
Package Description: | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-383-02) |
NDC Code | 68180-383-02 |
Proprietary Name | Tramadol Hydrochloride |
Package Description | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68180-383-02) |
Product NDC | 68180-383 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Tramadol Hydrochloride |
Dosage Form Name | TABLET, EXTENDED RELEASE |
Route Name | ORAL |
Start Marketing Date | 20110826 |
Marketing Category Name | ANDA |
Labeler Name | LUPIN PHARMACEUTICALS INC |
Substance Name | TRAMADOL HYDROCHLORIDE |
Strength Number | 100 |
Strength Unit | mg/1 |
Pharmaceutical Classes | Full Opioid Agonists [MoA],Opioid Agonist [EPC] |