"84441-713-10" National Drug Code (NDC)

Loperamide Hydrochloride And Simethicone 100 TABLET in 1 BOTTLE (84441-713-10)
(IMO-GEN LABS LLC)

NDC Code84441-713-10
Package Description100 TABLET in 1 BOTTLE (84441-713-10)
Product NDC84441-713
Product Type NameHUMAN OTC DRUG
Proprietary NameLoperamide Hydrochloride And Simethicone
Non-Proprietary NameLoperamide Hydrochloride And Simethicone
Dosage FormTABLET
UsageORAL
Start Marketing Date20251023
Marketing Category NameANDA
Application NumberANDA211438
ManufacturerIMO-GEN LABS 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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