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Tramadol Hydrochloride and Acetaminophen - 68382-334-01 - (Tramadol Hydrochloride and Acetaminophen)

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Drug Information of Tramadol Hydrochloride and Acetaminophen

Product NDC: 68382-334
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)

Labeler Information of Tramadol Hydrochloride and Acetaminophen

Product NDC: 68382-334
Labeler Name: Zydus Pharmaceuticals (USA) Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA090460
Marketing Category: ANDA
Start Marketing Date: 20121015

Package Information of Tramadol Hydrochloride and Acetaminophen

Package NDC: 68382-334-01
Package Description: 100 TABLET, FILM COATED in 1 BOTTLE (68382-334-01)

NDC Information of Tramadol Hydrochloride and Acetaminophen

NDC Code 68382-334-01
Proprietary Name Tramadol Hydrochloride and Acetaminophen
Package Description 100 TABLET, FILM COATED in 1 BOTTLE (68382-334-01)
Product NDC 68382-334
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 20121015
Marketing Category Name ANDA
Labeler Name Zydus Pharmaceuticals (USA) Inc.
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]

Complete Information of Tramadol Hydrochloride and Acetaminophen


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