"70000-0582-1" National Drug Code (NDC)

Leader Acid Reducer Complete 50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)
(Cardinal Health 110, LLC. dba Leader)

NDC Code70000-0582-1
Package Description50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)
Product NDC70000-0582
Product Type NameHUMAN OTC DRUG
Proprietary NameLeader Acid Reducer Complete
Non-Proprietary NameFamotidine, Calcium Carbonate And Magnesium Hydroxide
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20211214
Marketing Category NameANDA
Application NumberANDA077355
ManufacturerCardinal Health 110, LLC. dba Leader
Substance NameCALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Strength800; 10; 165
Strength Unitmg/1; mg/1; mg/1
Pharmacy ClassesCalculi Dissolution Agent [EPC], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]

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