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"70518-4247-0" National Drug Code (NDC)

Topiramate 30 POUCH in 1 BOX (70518-4247-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4247-1)
(REMEDYREPACK INC.)

NDC Code70518-4247-0
Package Description30 POUCH in 1 BOX (70518-4247-0) / 1 CAPSULE, COATED PELLETS in 1 POUCH (70518-4247-1)
Product NDC70518-4247
Product Type NameHUMAN PRESCRIPTION DRUG
Proprietary NameTopiramate
Non-Proprietary NameTopiramate
Dosage FormCAPSULE, COATED PELLETS
UsageORAL
Start Marketing Date20241224
Marketing Category NameANDA
Application NumberANDA078877
ManufacturerREMEDYREPACK INC.
Substance NameTOPIRAMATE
Strength25
Strength Unitmg/1
Pharmacy ClassesCytochrome P450 2C19 Inhibitors [MoA], Cytochrome P450 3A4 Inducers [MoA], Decreased Central Nervous System Disorganized Electrical Activity [PE]

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