"43386-118-03" National Drug Code (NDC)

Hydrocodone Bitartrate And Homatropine Methylbromide 30 TABLET in 1 BOTTLE (43386-118-03)
(Lupin Pharmaceuticals,Inc.)

NDC Code43386-118-03
Package Description30 TABLET in 1 BOTTLE (43386-118-03)
Product NDC43386-118
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Homatropine Methylbromide
Non-Proprietary NameHydrocodone Bitartrate And Homatropine Methylbromide
Dosage FormTABLET
UsageORAL
Start Marketing Date20140923
Marketing Category NameANDA
Application NumberANDA091528
ManufacturerLupin Pharmaceuticals,Inc.
Substance NameHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength1.5; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA]
DEA ScheduleCII

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