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Hydrocodone Bitartrate and Acetaminophen Tablets - 53746-109-01 - (Hydrocodone Bitartrate and Acetaminophen)

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Drug Information of Hydrocodone Bitartrate and Acetaminophen Tablets

Product NDC: 53746-109
Proprietary Name: Hydrocodone Bitartrate and Acetaminophen Tablets
Non Proprietary Name: Hydrocodone Bitartrate and Acetaminophen
Active Ingredient(s): 325; 5    mg/1; mg/1 & nbsp;   Hydrocodone Bitartrate and Acetaminophen
Administration Route(s): ORAL
Dosage Form(s): TABLET
Coding System: National Drug Codes(NDC)

Labeler Information of Hydrocodone Bitartrate and Acetaminophen Tablets

Product NDC: 53746-109
Labeler Name: Amneal Pharmaceuticals of NY, LLC
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040736
Marketing Category: ANDA
Start Marketing Date: 20100118

Package Information of Hydrocodone Bitartrate and Acetaminophen Tablets

Package NDC: 53746-109-01
Package Description: 100 TABLET in 1 BOTTLE (53746-109-01)

NDC Information of Hydrocodone Bitartrate and Acetaminophen Tablets

NDC Code 53746-109-01
Proprietary Name Hydrocodone Bitartrate and Acetaminophen Tablets
Package Description 100 TABLET in 1 BOTTLE (53746-109-01)
Product NDC 53746-109
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name Hydrocodone Bitartrate and Acetaminophen
Dosage Form Name TABLET
Route Name ORAL
Start Marketing Date 20100118
Marketing Category Name ANDA
Labeler Name Amneal Pharmaceuticals of NY, LLC
Substance Name ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength Number 325; 5
Strength Unit mg/1; mg/1
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA]

Complete Information of Hydrocodone Bitartrate and Acetaminophen Tablets


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