"60290-058-01" National Drug Code (NDC)

Carbamazepine 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-058-01)
(UMEDICA LABORATORIES PRIVATE LIMITED)

NDC Code60290-058-01
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (60290-058-01)
Product NDC60290-058
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCarbamazepine
Non-Proprietary NameCarbamazepine
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20220820
Marketing Category NameANDA
Application NumberANDA216594
ManufacturerUMEDICA LABORATORIES PRIVATE LIMITED
Substance NameCARBAMAZEPINE
Strength100
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 1A2 Inducers [MoA], Cytochrome P450 2B6 Inducers [MoA], Cytochrome P450 2C19 Inducers [MoA], Cytochrome P450 2C9 Inducers [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE], Mood Stabilizer [EPC]

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