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HYDROCODONE BIT/APAP - HYDROCODONE BITARTRATE AND ACETAMINOPHEN

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Field Value
NDC Code: 45865-411
Proprietary Name: HYDROCODONE BIT/APAP
Suffix:
Non-Proprietary Name: HYDROCODONE BITARTRATE AND ACETAMINOPHEN
Dosage Form: TABLET
Method: ORAL
Original Marketing Date: 01-07-2011
Category Name: ANDA
Application Number: ANDA040400
Labeler: MEDSOURCE PHARMACEUTICALS
Substance Name: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active Numerator Strength: 325; 10
Active Ingredient Unit: mg/1; mg/1
Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA Schedule: CIII