"70000-0316-1" National Drug Code (NDC)

Leader Acid Reducer Complete 25 TABLET, CHEWABLE in 1 BOTTLE (70000-0316-1)
(Cardinal Health 110, LLC. dba Leader)

NDC Code70000-0316-1
Package Description25 TABLET, CHEWABLE in 1 BOTTLE (70000-0316-1)
Product NDC70000-0316
Product Type NameHUMAN OTC DRUG
Proprietary NameLeader Acid Reducer Complete
Non-Proprietary NameFamotidine, Calcium Carbonate, Magnesium Hydroxide
Dosage FormTABLET, CHEWABLE
UsageORAL
Start Marketing Date20200115
Marketing Category NameANDA
Application NumberANDA204782
ManufacturerCardinal Health 110, LLC. dba Leader
Substance NameCALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
Strength800; 10; 165
Strength Unitmg/1; mg/1; mg/1
Pharmacy ClassesBlood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Histamine H2 Receptor Antagonists [MoA], Histamine-2 Receptor Antagonist [EPC], Increased Coagulation Factor Activity [PE], 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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