"0095-9090-16" National Drug Code (NDC)

Lortab 473 mL in 1 BOTTLE, PLASTIC (0095-9090-16)
(ECR Pharmaceuticals)

NDC Code0095-9090-16
Package Description473 mL in 1 BOTTLE, PLASTIC (0095-9090-16)
Product NDC0095-9090
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameLortab
Non-Proprietary NameHydrocodone Bitartrate And Acetaminophen
Dosage FormSYRUP
UsageORAL
Start Marketing Date20130925
Marketing Category NameANDA
Application NumberANDA040881
ManufacturerECR Pharmaceuticals
Substance NameHYDROCODONE BITARTRATE; ACETAMINOPHEN
Strength10; 300
Strength Unitmg/15mL; mg/15mL
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA]
DEA ScheduleCIII

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