"42794-016-08" National Drug Code (NDC)

Asenapine 30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)
(Sigmapharm Laboratories, LLC)

NDC Code42794-016-08
Package Description30 TABLET in 1 BOTTLE, PLASTIC (42794-016-08)
Product NDC42794-016
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameAsenapine
Non-Proprietary NameAsenapine
Dosage FormTABLET
UsageSUBLINGUAL
Start Marketing Date20201214
Marketing Category NameANDA
Application NumberANDA206107
ManufacturerSigmapharm Laboratories, LLC
Substance NameASENAPINE
Strength5
Strength Unitmg/1
Pharmacy ClassesAtypical Antipsychotic [EPC]

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