"76385-106-17" National Drug Code (NDC)

Ketotifen Fumarate 1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) > 5 mL in 1 BOTTLE, PLASTIC
(Bayshore Pharmaceuticals, LLC)

NDC Code76385-106-17
Package Description1 BOTTLE, PLASTIC in 1 CARTON (76385-106-17) > 5 mL in 1 BOTTLE, PLASTIC
Product NDC76385-106
Product Type NameHUMAN OTC DRUG
Proprietary NameKetotifen Fumarate
Non-Proprietary NameKetotifen Fumarate
Dosage FormSOLUTION
UsageOPHTHALMIC
Start Marketing Date20211015
Marketing Category NameANDA
Application NumberANDA204059
ManufacturerBayshore Pharmaceuticals, LLC
Substance NameKETOTIFEN FUMARATE
Strength.25
Strength Unitmg/mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]

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