"58602-868-76" National Drug Code (NDC)

Loperamide Hydrochloride And Simethicone 4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK
(Aurohealth LLC)

NDC Code58602-868-76
Package Description4 BLISTER PACK in 1 CARTON (58602-868-76) / 6 TABLET in 1 BLISTER PACK
Product NDC58602-868
Product Type NameHUMAN OTC DRUG
Proprietary NameLoperamide Hydrochloride And Simethicone
Non-Proprietary NameLoperamide Hydrochloride And Simethicone
Dosage FormTABLET
UsageORAL
Start Marketing Date20210224
Marketing Category NameANDA
Application NumberANDA211059
ManufacturerAurohealth LLC
Substance NameDIMETHICONE; LOPERAMIDE HYDROCHLORIDE
Strength125; 2
Strength Unitmg/1; mg/1
Pharmacy ClassesOpioid Agonist [EPC], Opioid Agonists [MoA], Skin Barrier Activity [PE]

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