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HYDROCODONE BITARTRATE AND ACETAMINOPHEN - 0406-0375-16 - (hydrocodone bitartrate and acetaminophen)

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Drug Information of HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 0406-0375
Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Non Proprietary Name: hydrocodone bitartrate and acetaminophen
Active Ingredient(s): 500; 7.5    mg/15mL; mg/15mL & nbsp;   hydrocodone bitartrate and acetaminophen
Administration Route(s): ORAL
Dosage Form(s): SOLUTION
Coding System: National Drug Codes(NDC)

Labeler Information of HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Product NDC: 0406-0375
Labeler Name: Mallinckrodt, Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA040418
Marketing Category: ANDA
Start Marketing Date: 20110622

Package Information of HYDROCODONE BITARTRATE AND ACETAMINOPHEN

Package NDC: 0406-0375-16
Package Description: 473 mL in 1 BOTTLE (0406-0375-16)

NDC Information of HYDROCODONE BITARTRATE AND ACETAMINOPHEN

NDC Code 0406-0375-16
Proprietary Name HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Package Description 473 mL in 1 BOTTLE (0406-0375-16)
Product NDC 0406-0375
Product Type Name HUMAN PRESCRIPTION DRUG
Non Proprietary Name hydrocodone bitartrate and acetaminophen
Dosage Form Name SOLUTION
Route Name ORAL
Start Marketing Date 20110622
Marketing Category Name ANDA
Labeler Name Mallinckrodt, Inc.
Substance Name ACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength Number 500; 7.5
Strength Unit mg/15mL; mg/15mL
Pharmaceutical Classes Opioid Agonist [EPC],Opioid Agonists [MoA]

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