"69452-531-12" National Drug Code (NDC)

Loperamide Hydrochloride And Simethicone 4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK
(Bionpharma Inc.)

NDC Code69452-531-12
Package Description4 BLISTER PACK in 1 CARTON (69452-531-12) / 6 TABLET in 1 BLISTER PACK
Product NDC69452-531
Product Type NameHUMAN OTC DRUG
Proprietary NameLoperamide Hydrochloride And Simethicone
Non-Proprietary NameLoperamide Hydrochloride And Simethicone
Dosage FormTABLET
UsageORAL
Start Marketing Date20260107
Marketing Category NameANDA
Application NumberANDA213484
ManufacturerBionpharma Inc.
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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