"70518-3825-0" National Drug Code (NDC)

NDC Code	70518-3825-0
Package Description	100 POUCH in 1 BOX (70518-3825-0) / 1 TABLET, EXTENDED RELEASE in 1 POUCH (70518-3825-1)
Product NDC	70518-3825
Product Type Name	HUMAN PRESCRIPTION DRUG
Proprietary Name	Carbamazepine
Non-Proprietary Name	Carbamazepine
Dosage Form	TABLET, EXTENDED RELEASE
Usage	ORAL
Start Marketing Date	20230809
Marketing Category Name	ANDA
Application Number	ANDA213311
Manufacturer	REMEDYREPACK INC.
Substance Name	CARBAMAZEPINE
Strength	400
Strength Unit	mg/1
Pharmacy Classes	Cytochrome 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]