dual action complete (37808-503)

Drug Facts

Product Profile

Brand Name dual action complete

Generic Name famotidine, calcium carbonate and magnesium hydroxide

Labeler h e b

Dosage Form TABLET, CHEWABLE

Routes

ORAL

Active Ingredients

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

Manufacturer

H E B

Identifiers & Regulatory

Product NDC 37808-503

Product ID 37808-503_5acd6b6c-44e0-442f-9d00-9f1a5be68c83

Product Type HUMAN OTC DRUG

Marketing Category ANDA

Application Number ANDA077355

Listing Expiration 2026-12-31

Marketing Start 2016-04-07

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 37808503

Hyphenated Format 37808-503

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 dual action 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

25 TABLET, CHEWABLE in 1 BOTTLE (37808-503-63)
50 TABLET, CHEWABLE in 1 BOTTLE (37808-503-71)

source: ndc

Packages (2)

37808-503-63 25 TABLET, CHEWABLE in 1 BOTTLE (37808-503-63) 37808-503-71 50 TABLET, CHEWABLE in 1 BOTTLE (37808-503-71)

Ingredients (3)

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

Linked Drug Pages (1)

Dual Action Complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["ORAL"], "spl_id": "5acd6b6c-44e0-442f-9d00-9f1a5be68c83", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["H0G9379FGK", "5QZO15J2Z8", "NBZ3QY004S"], "rxcui": ["283641"], "spl_set_id": ["c1aa7efa-4be1-4c8f-8994-661dd60e1aa9"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["H E B"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET, CHEWABLE in 1 BOTTLE (37808-503-63)", "package_ndc": "37808-503-63", "marketing_start_date": "20160407"}, {"sample": false, "description": "50 TABLET, CHEWABLE in 1 BOTTLE (37808-503-71)", "package_ndc": "37808-503-71", "marketing_start_date": "20210610"}], "brand_name": "Dual Action Complete", "product_id": "37808-503_5acd6b6c-44e0-442f-9d00-9f1a5be68c83", "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": "37808-503", "generic_name": "famotidine, calcium carbonate and magnesium hydroxide", "labeler_name": "H E B", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Dual Action 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": "20160407", "listing_expiration_date": "20261231"}