"36800-097-05" National Drug Code (NDC)

Eye Itch Relief 1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPER
(TOPCO ASSOCIATES LLC)

NDC Code36800-097-05
Package Description1 BOTTLE, DROPPER in 1 CARTON (36800-097-05) / 5 mL in 1 BOTTLE, DROPPER
Product NDC36800-097
Product Type NameHUMAN OTC DRUG
Proprietary NameEye Itch Relief
Non-Proprietary NameKetotifen Fumarate
Dosage FormSOLUTION/ DROPS
UsageOPHTHALMIC
Start Marketing Date20220315
Marketing Category NameNDA
Application NumberNDA021996
ManufacturerTOPCO ASSOCIATES LLC
Substance NameKETOTIFEN FUMARATE
Strength.25
Strength Unitmg/mL
Pharmacy ClassesHistamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Inhibitor [EPC]

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