"53041-263-50" National Drug Code (NDC)

Loperamide Hydrochloride, Simethicone 1 BLISTER PACK in 1 CARTON (53041-263-50) > 6 TABLET in 1 BLISTER PACK
(Guardian Drug Company)

NDC Code53041-263-50
Package Description1 BLISTER PACK in 1 CARTON (53041-263-50) > 6 TABLET in 1 BLISTER PACK
Product NDC53041-263
Product Type NameHUMAN OTC DRUG
Proprietary NameLoperamide Hydrochloride, Simethicone
Non-Proprietary NameLoperamide Hydrochloride, Simethicone
Dosage FormTABLET
UsageORAL
Start Marketing Date20210601
Marketing Category NameANDA
Application NumberANDA214541
ManufacturerGuardian Drug Company
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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