"35561-355-12" National Drug Code (NDC)

Carbamazepine Er 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12)
(AustarPharma LLC)

NDC Code35561-355-12
Package Description100 TABLET, EXTENDED RELEASE in 1 BOTTLE (35561-355-12)
Product NDC35561-355
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCarbamazepine Er
Non-Proprietary NameCarbamazepine
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20211209
Marketing Category NameANDA
Application NumberANDA215591
ManufacturerAustarPharma LLC
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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