"76181-001-25" National Drug Code (NDC)

Hydrocodone Bitartrate And Acetaminophen 473 mL in 1 BOTTLE, PLASTIC (76181-001-25)
(Talec Pharma, LLC)

NDC Code76181-001-25
Package Description473 mL in 1 BOTTLE, PLASTIC (76181-001-25)
Product NDC76181-001
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Acetaminophen
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSYRUP
UsageORAL
Start Marketing Date20110801
Marketing Category NameANDA
Application NumberANDA040482
ManufacturerTalec Pharma, LLC
Substance NameACETAMINOPHEN; HYDROCODONE BITARTRATE
Strength325; 7.5
Strength Unitmg/15mL; mg/15mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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