"70518-3591-0" National Drug Code (NDC)

Carbamazepine 100 POUCH in 1 BOX (70518-3591-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3591-1)
(REMEDYREPACK INC.)

NDC Code70518-3591-0
Package Description100 POUCH in 1 BOX (70518-3591-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3591-1)
Product NDC70518-3591
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCarbamazepine
Non-Proprietary NameCarbamazepine
Dosage FormTABLET, EXTENDED RELEASE
UsageORAL
Start Marketing Date20221207
Marketing Category NameANDA
Application NumberANDA211623
ManufacturerREMEDYREPACK INC.
Substance NameCARBAMAZEPINE
Strength400
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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