pepcid complete

Generic: famotidine, calcium carbonate, and magnesium hydroxide

Labeler: kenvue brands llc
NDC Directory HUMAN OTC DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name pepcid complete
Generic Name famotidine, calcium carbonate, and magnesium hydroxide
Labeler kenvue brands llc
Dosage Form TABLET, CHEWABLE
Routes
ORAL
Active Ingredients

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

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 16837-246
Product ID 16837-246_42d92ca2-a860-6e60-e063-6294a90af5b5
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020958
Listing Expiration 2026-12-31
Marketing Start 2009-01-01

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 16837246
Hyphenated Format 16837-246

Supplemental Identifiers

RxCUI
283641 688892
UPC
0716837246251
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 pepcid complete (source: ndc)
Generic Name famotidine, calcium carbonate, and magnesium hydroxide (source: ndc)
Application Number NDA020958 (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, PLASTIC (16837-246-25)
  • 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)
source: ndc

Packages (2)

16837-246-25 25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25) 16837-246-50 50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)

Ingredients (3)

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

Linked Drug Pages (1)

Pepcid Complete ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "42d92ca2-a860-6e60-e063-6294a90af5b5", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0716837246251"], "unii": ["H0G9379FGK", "5QZO15J2Z8", "NBZ3QY004S"], "rxcui": ["283641", "688892"], "spl_set_id": ["37e6a3f6-5261-475d-a7d4-e72854088982"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Kenvue Brands LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-25)", "package_ndc": "16837-246-25", "marketing_start_date": "20090101"}, {"sample": false, "description": "50 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (16837-246-50)", "package_ndc": "16837-246-50", "marketing_start_date": "20090101"}], "brand_name": "Pepcid Complete", "product_id": "16837-246_42d92ca2-a860-6e60-e063-6294a90af5b5", "dosage_form": "TABLET, CHEWABLE", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "16837-246", "generic_name": "Famotidine, Calcium Carbonate, and Magnesium Hydroxide", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepcid 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": "NDA020958", "marketing_category": "NDA", "marketing_start_date": "20090101", "listing_expiration_date": "20261231"}