famotidine

Generic: famotidine

Labeler: fred's, inc.
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name famotidine
Generic Name famotidine
Labeler fred's, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Fred's, Inc.

Identifiers & Regulatory

Product NDC 55315-435
Product ID 55315-435_8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA206531
Listing Expiration 2026-12-31
Marketing Start 2016-04-26

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 55315435
Hyphenated Format 55315-435

Supplemental Identifiers

RxCUI
310273
UPC
0358602828196
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 famotidine (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA206531 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (55315-435-53) / 25 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

55315-435-53 1 BOTTLE in 1 CARTON (55315-435-53) / 25 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

Famotidine ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0", "openfda": {"nui": ["N0000000151", "N0000175784"], "upc": ["0358602828196"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["81b105a1-01fe-51d7-e053-2991aa0a71bc"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Fred's, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (55315-435-53)  / 25 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "55315-435-53", "marketing_start_date": "20160426"}], "brand_name": "Famotidine", "product_id": "55315-435_8dd0ce14-1eb8-4c4a-9f4a-2671fabfa7c0", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "55315-435", "generic_name": "Famotidine", "labeler_name": "Fred's, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Famotidine", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA206531", "marketing_category": "ANDA", "marketing_start_date": "20160426", "listing_expiration_date": "20261231"}