leader acid reducer complete (70000-0582)

Drug Facts

Product Profile

Brand Name leader acid reducer complete

Generic Name famotidine, calcium carbonate and magnesium hydroxide

Labeler cardinal health 110, llc. dba leader

Dosage Form TABLET, CHEWABLE

Routes

ORAL

Active Ingredients

calcium carbonate 800 mg/1, famotidine 10 mg/1, magnesium hydroxide 165 mg/1

Manufacturer

Cardinal Health 110, LLC. dba Leader

Identifiers & Regulatory

Product NDC 70000-0582

Product ID 70000-0582_60031720-d6d7-4794-b842-928619aa82eb

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA077355

Listing Expiration 2026-12-31

Marketing Start 2021-12-14

Pharmacologic Class

Established (EPC)

histamine-2 receptor antagonist [epc]

Mechanism of Action

histamine h2 receptor antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 700000582

Hyphenated Format 70000-0582

Supplemental Identifiers

RxCUI

283641

UNII

H0G9379FGK 5QZO15J2Z8 NBZ3QY004S

NUI

N0000000151 N0000175784

Packaging Origin

Original Packager

true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name leader acid reducer complete (source: ndc)

Generic Name famotidine, calcium carbonate and magnesium hydroxide (source: ndc)

Application Number ANDA077355 (source: ndc)

Routes

ORAL

source: ndc

Resolved Composition

Strengths

800 mg/1
10 mg/1
165 mg/1

source: ndc

Packaging

50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)

source: ndc

Packages (1)

70000-0582-1 50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)

Ingredients (3)

calcium carbonate (800 mg/1) famotidine (10 mg/1) magnesium hydroxide (165 mg/1)

Linked Drug Pages (1)

leader acid reducer complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "60031720-d6d7-4794-b842-928619aa82eb", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["H0G9379FGK", "5QZO15J2Z8", "NBZ3QY004S"], "rxcui": ["283641"], "spl_set_id": ["a5420ef1-313f-4561-baf1-7ae017ea343a"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Cardinal Health 110, LLC. dba Leader"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 TABLET, CHEWABLE in 1 BOTTLE (70000-0582-1)", "package_ndc": "70000-0582-1", "marketing_start_date": "20211214"}], "brand_name": "leader acid reducer complete", "product_id": "70000-0582_60031720-d6d7-4794-b842-928619aa82eb", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Calculi 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]"], "product_ndc": "70000-0582", "generic_name": "famotidine, calcium carbonate and magnesium hydroxide", "labeler_name": "Cardinal Health 110, LLC. dba Leader", "product_type": "HUMAN OTC DRUG", "brand_name_base": "leader acid reducer complete", "active_ingredients": [{"name": "CALCIUM CARBONATE", "strength": "800 mg/1"}, {"name": "FAMOTIDINE", "strength": "10 mg/1"}, {"name": "MAGNESIUM HYDROXIDE", "strength": "165 mg/1"}], "application_number": "ANDA077355", "marketing_category": "ANDA", "marketing_start_date": "20211214", "listing_expiration_date": "20261231"}