pepcid ac maximum strength

Generic: famotidine

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

Drug Facts

Product Profile

Brand Name pepcid ac maximum strength
Generic Name famotidine
Labeler kenvue brands llc
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 16837-855
Product ID 16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020325
Listing Expiration 2026-12-31
Marketing Start 2003-09-01

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 16837855
Hyphenated Format 16837-855

Supplemental Identifiers

RxCUI
104094 310273
UPC
0716837855255
UNII
5QZO15J2Z8
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 ac maximum strength (source: ndc)
Generic Name famotidine (source: ndc)
Application Number NDA020325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 TABLET, FILM COATED in 1 POUCH (16837-855-13)
  • 5 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK
  • 2 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 2500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 50 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)
source: ndc

Packages (18)

16837-855-02 2 POUCH in 1 CARTON (16837-855-02) / 1 TABLET, FILM COATED in 1 POUCH 16837-855-09 1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-12 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-13 1 TABLET, FILM COATED in 1 POUCH (16837-855-13) 16837-855-14 5 BLISTER PACK in 1 CARTON (16837-855-14) / 5 TABLET, FILM COATED in 1 BLISTER PACK 16837-855-15 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15) / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-16 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-18 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-19 1 BLISTER PACK in 1 CARTON (16837-855-19) / 8 TABLET, FILM COATED in 1 BLISTER PACK 16837-855-20 2 CARTON in 1 PACKAGE (16837-855-20) / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-24 2500 POUCH in 1 CARTON (16837-855-24) / 1 TABLET, FILM COATED in 1 POUCH 16837-855-50 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50) / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-52 50 POUCH in 1 TRAY (16837-855-52) / 1 TABLET, FILM COATED in 1 POUCH 16837-855-70 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70) / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-75 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75) / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-80 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80) / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-85 1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85) / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-855-90 125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

PEPCID AC Maximum Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "21af0de6-18c5-b8e8-e063-6394a90af51f", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0716837855255"], "unii": ["5QZO15J2Z8"], "rxcui": ["104094", "310273"], "spl_set_id": ["2854047f-c5c4-43c3-8ef2-5c0a84a307f2"], "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": "2 POUCH in 1 CARTON (16837-855-02)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "16837-855-02", "marketing_start_date": "20230605"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 PACKAGE (16837-855-09)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-09", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-12)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-12", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 TABLET, FILM COATED in 1 POUCH (16837-855-13)", "package_ndc": "16837-855-13", "marketing_start_date": "20030901"}, {"sample": false, "description": "5 BLISTER PACK in 1 CARTON (16837-855-14)  / 5 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "16837-855-14", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-15)  / 35 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-15", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-16)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-16", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-18)  / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-18", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (16837-855-19)  / 8 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "16837-855-19", "marketing_start_date": "20150427"}, {"sample": false, "description": "2 CARTON in 1 PACKAGE (16837-855-20)  / 1 BOTTLE, PLASTIC in 1 CARTON / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-20", "marketing_start_date": "20140822"}, {"sample": false, "description": "2500 POUCH in 1 CARTON (16837-855-24)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "16837-855-24", "marketing_start_date": "20230605"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-50)  / 50 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-50", "marketing_start_date": "20030901"}, {"sample": false, "description": "50 POUCH in 1 TRAY (16837-855-52)  / 1 TABLET, FILM COATED in 1 POUCH", "package_ndc": "16837-855-52", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-70)  / 70 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-70", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-75)  / 75 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-75", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-80)  / 80 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-80", "marketing_start_date": "20030901"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-855-85)  / 85 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-855-85", "marketing_start_date": "20030901"}, {"sample": false, "description": "125 TABLET, FILM COATED in 1 PACKAGE, COMBINATION (16837-855-90)", "package_ndc": "16837-855-90", "marketing_start_date": "20210315"}], "brand_name": "PEPCID AC Maximum Strength", "product_id": "16837-855_21af0de6-18c5-b8e8-e063-6394a90af51f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "16837-855", "generic_name": "Famotidine", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PEPCID AC", "brand_name_suffix": "Maximum Strength", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "NDA020325", "marketing_category": "NDA", "marketing_start_date": "20030901", "listing_expiration_date": "20261231"}