Product NDC: | 42571-119 |
Proprietary Name: | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
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, FILM COATED |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 42571-119 |
Labeler Name: | Micro Labs Limited |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | ANDA201952 |
Marketing Category: | ANDA |
Start Marketing Date: | 20121215 |
Package NDC: | 42571-119-23 |
Package Description: | 8 BLISTER PACK in 1 CARTON (42571-119-23) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-119-32) |
NDC Code | 42571-119-23 |
Proprietary Name | TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN |
Package Description | 8 BLISTER PACK in 1 CARTON (42571-119-23) > 10 TABLET, FILM COATED in 1 BLISTER PACK (42571-119-32) |
Product NDC | 42571-119 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | Tramadol hydrochloride and Acetaminophen |
Dosage Form Name | TABLET, FILM COATED |
Route Name | ORAL |
Start Marketing Date | 20121215 |
Marketing Category Name | ANDA |
Labeler Name | Micro Labs Limited |
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] |