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Hydrocodone Bitartate and Acetaminophen - HYDROCODONE BITARTRATE, ACETAMINOPHEN

Navigation: NDC > Supplier starting with: K > KLE 2, INC.
Field Value
NDC Code: 76218-1828
Proprietary Name: Hydrocodone Bitartate and Acetaminophen
Suffix:
Non-Proprietary Name: HYDROCODONE BITARTRATE, ACETAMINOPHEN
Dosage Form: TABLET
Method: ORAL
Original Marketing Date: 17-05-2012
Category Name: ANDA
Application Number: ANDA040846
Labeler: KLE 2, INC.
Substance Name: ACETAMINOPHEN; HYDROCODONE BITARTRATE
Active Numerator Strength: 325; 2.5
Active Ingredient Unit: mg/1; mg/1
Pharm Classes: Opioid Agonist [EPC],Opioid Agonists [MoA]
DEA Schedule: CIII