"0121-0947-94" National Drug Code (NDC)

Carbamazepine 3 TRAY in 1 CASE (0121-0947-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0947-05)
(PAI Holdings, LLC)

NDC Code0121-0947-94
Package Description3 TRAY in 1 CASE (0121-0947-94) / 10 CUP, UNIT-DOSE in 1 TRAY / 5 mL in 1 CUP, UNIT-DOSE (0121-0947-05)
Product NDC0121-0947
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameCarbamazepine
Non-Proprietary NameCarbamazepine
Dosage FormSUSPENSION
UsageORAL
Start Marketing Date20211007
Marketing Category NameANDA
Application NumberANDA076729
ManufacturerPAI Holdings, LLC
Substance NameCARBAMAZEPINE
Strength100
Strength Unitmg/5mL
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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