FDA.reportPublic FDA data

NDC 80425-0329-01 - Famotidine

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
80425-0329
Requested NDC
80425-0329-01
Package NDCs from labels
80425-0329-1, 80425-0329-2, 80425-0329-3, 80425-0329-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-12-31
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-12-31HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0329-1Famotidine30 in 1 BOTTLETABLET, FILM COATED302
80425-0329-2Famotidine60 in 1 BOTTLETABLET, FILM COATED602
80425-0329-3Famotidine90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0329FAMOTIDINE TABLET, FILM COATED [ADVANCED RX PHARMACY OF TENNESSEE, LLC]2Current NDC, 3 package rows20250102_fa18ed52-f038-02dd-e053-6394a90ac946.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0329-1EA - Each80425-03290cc68a21-b01f-429f-9086-d78b7fbf45f512023-06-06
80425-0329-2EA - Each80425-03290fc519ef-64eb-49d5-92ce-8a03006dbe4712024-06-10
80425-0329-3EA - Each80425-0329f5383420-4305-45d1-a32a-a69a86bbc45412024-06-10

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 7 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.2f5ec69d-926c-47a2-be47-8fef2e0ff2072025-10-14Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 284245
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEBryant Ranch Prepackc133a9e1-ca48-4ee2-8768-01f44f5dd5112025-10-14Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEA-S Medication Solutions3c32f8e2-f54a-422d-9c25-68692ea090012025-10-10Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a3b50576-cd40-4f7e-9506-bd0a619884242025-10-09Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
Zantac 360 Cool MintFAMOTIDINEChattem, Inc.19fe7c6e-243c-4005-a63a-f8cac1ce55c82025-09-30WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEBryant Ranch Prepacke034546b-28cb-41aa-9441-655cdb9665542025-09-29Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 284245
unii: 5QZO15J2Z8
equaline heartburn preventionFAMOTIDINEUnited Natural Foods, Inc. dba UNFIf40f1dcf-249a-4ccb-bdfc-acff49dd4a152025-09-25WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.5ed77259-5dd9-4634-a073-346693488c4f2025-09-23Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx3f16596d-dd5a-7985-e063-6294a90a6f9d2025-09-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Up and Up Dual Action Acid Reducer and AntacidFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETarget Corporation2f020677-77a0-4e13-9397-e9deeda632932025-09-10WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.6edbd842-cf86-48a5-bc22-967620a2b5cb2025-09-05Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
basic care heartburn preventionFAMOTIDINEAmazon.com Services LLC8d57f6db-a9f0-4416-9f49-17ce3571b0aa2025-09-04WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDETopco Associates LLC2c5a1694-d6e9-4679-b421-61eaad5403a42025-09-04WarningsExact identifier
unii: 5QZO15J2Z8
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmerican Sales Company5d4bea42-25d5-4943-b5ed-471eccd36bf82025-08-29WarningsExact identifier
unii: 5QZO15J2Z8
CareOne Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEAmerican Sales Company19045840-2d25-43af-8c92-f36c8b903b282025-08-28WarningsExact identifier
unii: 5QZO15J2Z8
ACID REDUCER COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDESafeway484ad323-82cf-4157-bacb-236af8210c872025-08-27WarningsExact identifier
unii: 5QZO15J2Z8
careone acid reliefFAMOTIDINERetail Business Services, LLC2f0f90cf-8f9a-4102-aab6-941aa0d35e4f2025-08-26WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
maximum strengthFAMOTIDINEPublix Super Markets Incf692ed61-d09a-484e-bf07-8afcedfb32082025-08-21WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Leader Acid ReducerFAMOTIDINECardinal Health 110, LLC. dba Leader321b83f9-4bbf-494a-9279-80b0742049b62025-08-21WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
foster and thrive acid reducerFAMOTIDINEStrategic Sourcing Services LLC0c480ba4-b07e-4109-a9a9-5480b4a39a1d2025-08-21WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.