pepcid ac original strength

Generic: famotidine

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

Drug Facts

Product Profile

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

famotidine 10 mg/1

Manufacturer
Kenvue Brands LLC

Identifiers & Regulatory

Product NDC 16837-872
Product ID 16837-872_4a227807-355e-b37d-e063-6394a90a7639
Product Type HUMAN OTC DRUG
Marketing Category NDA
Application Number NDA020325
Listing Expiration 2027-12-31
Marketing Start 1995-10-01

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 16837872
Hyphenated Format 16837-872

Supplemental Identifiers

RxCUI
199047 212072
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 original strength (source: ndc)
Generic Name famotidine (source: ndc)
Application Number NDA020325 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 10 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
  • 3 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK
  • 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC
source: ndc

Packages (4)

16837-872-20 3 BLISTER PACK in 1 CARTON (16837-872-20) / 10 TABLET, FILM COATED in 1 BLISTER PACK 16837-872-22 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-22) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 16837-872-30 3 BLISTER PACK in 1 CARTON (16837-872-30) / 10 TABLET, FILM COATED in 1 BLISTER PACK 16837-872-90 1 BOTTLE, PLASTIC in 1 CARTON (16837-872-90) / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC

Ingredients (1)

famotidine (10 mg/1)

Linked Drug Pages (1)

Pepcid AC Original Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "4a227807-355e-b37d-e063-6394a90a7639", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["199047", "212072"], "spl_set_id": ["54f4086f-e443-4e7e-8c7e-94e152e1c256"], "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": "3 BLISTER PACK in 1 CARTON (16837-872-20)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "16837-872-20", "marketing_start_date": "20110121"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-872-22)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-872-22", "marketing_start_date": "20110121"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (16837-872-30)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "16837-872-30", "marketing_start_date": "19951001"}, {"sample": false, "description": "1 BOTTLE, PLASTIC in 1 CARTON (16837-872-90)  / 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC", "package_ndc": "16837-872-90", "marketing_start_date": "19951001"}], "brand_name": "Pepcid AC Original Strength", "product_id": "16837-872_4a227807-355e-b37d-e063-6394a90a7639", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "16837-872", "generic_name": "Famotidine", "labeler_name": "Kenvue Brands LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Pepcid AC", "brand_name_suffix": "Original Strength", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "10 mg/1"}], "application_number": "NDA020325", "marketing_category": "NDA", "marketing_start_date": "19951001", "listing_expiration_date": "20271231"}