acid reducer

Generic: famotidine

Labeler: allegiant health
NDC Directory HUMAN OTC DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name acid reducer
Generic Name famotidine
Labeler allegiant health
Dosage Form TABLET
Routes
ORAL
Active Ingredients

famotidine 20 mg/1

Manufacturer
Allegiant Health

Identifiers & Regulatory

Product NDC 69168-443
Product ID 69168-443_10efebb0-5d63-4c46-8934-9e91b213a543
Product Type HUMAN OTC DRUG
Marketing Category ANDA
Application Number ANDA215822
Listing Expiration 2026-12-31
Marketing Start 2024-01-15

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 69168443
Hyphenated Format 69168-443

Supplemental Identifiers

RxCUI
310273
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 acid reducer (source: ndc)
Generic Name famotidine (source: ndc)
Application Number ANDA215822 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 20 mg/1
source: ndc
Packaging
  • 10 TABLET in 1 BLISTER PACK (69168-443-09)
  • 100 TABLET in 1 BOTTLE (69168-443-32)
  • 1 BOTTLE in 1 CARTON (69168-443-50) / 50 TABLET in 1 BOTTLE
  • 225 TABLET in 1 BOTTLE (69168-443-52)
  • 365 TABLET in 1 BOTTLE (69168-443-99)
source: ndc

Packages (5)

69168-443-09 10 TABLET in 1 BLISTER PACK (69168-443-09) 69168-443-32 100 TABLET in 1 BOTTLE (69168-443-32) 69168-443-50 1 BOTTLE in 1 CARTON (69168-443-50) / 50 TABLET in 1 BOTTLE 69168-443-52 225 TABLET in 1 BOTTLE (69168-443-52) 69168-443-99 365 TABLET in 1 BOTTLE (69168-443-99)

Ingredients (1)

famotidine (20 mg/1)

Linked Drug Pages (1)

Acid Reducer ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "10efebb0-5d63-4c46-8934-9e91b213a543", "openfda": {"nui": ["N0000000151", "N0000175784"], "unii": ["5QZO15J2Z8"], "rxcui": ["310273"], "spl_set_id": ["adc2721d-2ca7-4a47-bae1-be298fa1c155"], "pharm_class_epc": ["Histamine-2 Receptor Antagonist [EPC]"], "pharm_class_moa": ["Histamine H2 Receptor Antagonists [MoA]"], "manufacturer_name": ["Allegiant Health"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 TABLET in 1 BLISTER PACK (69168-443-09)", "package_ndc": "69168-443-09", "marketing_start_date": "20240229"}, {"sample": false, "description": "100 TABLET in 1 BOTTLE (69168-443-32)", "package_ndc": "69168-443-32", "marketing_start_date": "20240115"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (69168-443-50)  / 50 TABLET in 1 BOTTLE", "package_ndc": "69168-443-50", "marketing_start_date": "20240305"}, {"sample": false, "description": "225 TABLET in 1 BOTTLE (69168-443-52)", "package_ndc": "69168-443-52", "marketing_start_date": "20240115"}, {"sample": false, "description": "365 TABLET in 1 BOTTLE (69168-443-99)", "package_ndc": "69168-443-99", "marketing_start_date": "20241028"}], "brand_name": "Acid Reducer", "product_id": "69168-443_10efebb0-5d63-4c46-8934-9e91b213a543", "dosage_form": "TABLET", "pharm_class": ["Histamine H2 Receptor Antagonists [MoA]", "Histamine-2 Receptor Antagonist [EPC]"], "product_ndc": "69168-443", "generic_name": "Famotidine", "labeler_name": "Allegiant Health", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Acid Reducer", "active_ingredients": [{"name": "FAMOTIDINE", "strength": "20 mg/1"}], "application_number": "ANDA215822", "marketing_category": "ANDA", "marketing_start_date": "20240115", "listing_expiration_date": "20261231"}