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 9 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEChain Drug Marketing Association INC1d78bc9e-cf7b-8853-c6dc-b36e5de4dd0a2025-07-17WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
equate famotidineFAMOTIDINEWALMART INC.f38f8a8f-3292-4fe5-b83f-ffd634196d422025-07-16WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC397f1f23-10c2-569e-e063-6394a90a71642025-07-11Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leader6a492dd2-61f1-4020-bebd-fcc8e56472072025-07-08WarningsExact identifier
unii: 5QZO15J2Z8
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEKroger Companybf2fcb88-418f-4d5d-85ba-ec165a53ab042025-07-07WarningsExact identifier
unii: 5QZO15J2Z8
Equate Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEWal-Mart Stores Inccb683c1c-db81-40a9-9ec5-f8dfa0dcf8122025-07-07WarningsExact identifier
unii: 5QZO15J2Z8
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEH E Bea712fc4-7f27-4556-b1b8-028f3f6ce57a2025-07-07WarningsExact identifier
unii: 5QZO15J2Z8
DG Health acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEDolgencorp, LLC95c2c515-0f31-49d9-b799-7aaded81a37c2025-07-07WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINELittle Pharma, Inc.33dc93a5-ee03-2e68-e063-6294a90aeee12025-07-05WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAurobindo Pharma Limited21688404-41fb-487e-8ba0-aea4431a42fa2025-07-03Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
topcare dual action completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDETopco Associates LLC8ef70327-9a04-413b-b331-f5d3a94d6b362025-07-01WarningsExact identifier
unii: 5QZO15J2Z8
Acid Reducer CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEWalgreen Company3a456dab-0a2d-4e48-a8e2-e49a7acef9632025-07-01WarningsExact identifier
unii: 5QZO15J2Z8
Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEH E Bc1aa7efa-4be1-4c8f-8994-661dd60e1aa92025-07-01WarningsExact identifier
unii: 5QZO15J2Z8
leader acid reducer completeFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECardinal Health 110, LLC. dba Leadera5420ef1-313f-4561-baf1-7ae017ea343a2025-07-01WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEProficient Rx LP702dd4fa-4a78-454d-91c5-493894750f7b2025-07-01Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
acid controllerFAMOTIDINEH E B813d742f-8f3d-4f18-a6c5-03eea946f9762025-06-23WarningsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEMorning Star OTCbe7f97d5-d2f2-45a8-96b4-fed1549ae2a32025-06-19WarningsExact identifier
unii: 5QZO15J2Z8
TopCare Acid ReducerFAMOTIDINETopco Associates LLC88722f84-dac8-4130-93b3-9e0dc1cc5acc2025-06-13WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEFAMILY DOLLAR99698eea-6bf1-42e8-9f48-d58fc04373242025-06-06WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEDr.Reddys Laboratories Limited387088a6-8eaa-fc49-8050-a546d0f0fd322025-06-03WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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