"43386-350-03" National Drug Code (NDC)

Hydrocodone Bitartrate And Homatropine Methylbromide 30 TABLET in 1 BOTTLE (43386-350-03)
(GAVIS Pharmaceuticals, LLC)

NDC Code43386-350-03
Package Description30 TABLET in 1 BOTTLE (43386-350-03)
Product NDC43386-350
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameHydrocodone Bitartrate And Homatropine Methylbromide
Non-Proprietary NameHydrocodone Bitartrate And Homatropine Methylbromide
Dosage FormTABLET
UsageORAL
Start Marketing Date20110216
Marketing Category NameANDA
Application NumberANDA091528
ManufacturerGAVIS Pharmaceuticals, LLC
Substance NameHOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
Strength1.5; 5
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC],Opioid Agonists [MoA],Cholinergic Muscarinic Agonist [EPC],Cholinergic Muscarinic Agonists [MoA]
DEA ScheduleCIII

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