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 6 of 18 · 360 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINESAFEWAYf18c1195-48a1-69dc-e053-2a95a90a40772025-12-18WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINERedpharm Drug44f3f63d-4522-91e4-e063-6394a90a6d1b2025-12-02Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAjanta Pharma USA Inc.a88e7069-230c-4105-ade0-a98968e186712025-11-30Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDER J General Corporationf0e08608-e9b0-3203-e053-2995a90adfbd2025-11-17WarningsExact identifier
unii: 5QZO15J2Z8
Good Sense Dual Action CompleteFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEL. Perrigo Companyb7154648-8c8c-4ce6-88b7-5442a16143c52025-11-14WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINENovadoz Pharmaceuticals LLC74a24590-a0b6-4607-8e67-9fadce53389b2025-11-12Warnings, Adverse reactionsExact identifier
rxcui: 284245
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAvPAK85c7d20d-3dec-b918-4c1d-8ca1db214e482025-11-11Warnings, Adverse reactionsExact identifier
rxcui: 284245
rxcui: 310273
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLC37e6a3f6-5261-475d-a7d4-e728540889822025-11-05WarningsExact identifier
unii: 5QZO15J2Z8
famotidineFAMOTIDINEChartwell RX, LLC70714491-1368-4824-98af-03fda52139a92025-11-04Warnings, Adverse reactionsExact identifier
rxcui: 284245
rxcui: 310273
unii: 5QZO15J2Z8
Heartburn ReliefFAMOTIDINEShield Pharmaceuticals Corpa12ec91d-244f-45c5-8590-d1e4485fe3612025-10-31WarningsExact identifier
unii: 5QZO15J2Z8
careone acid reliefFAMOTIDINERetail Business Services, LLC8f654234-b25d-47d6-b1f8-f7f3535697952025-10-30WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Acid ControllerFAMOTIDINEH E B8aac5a0d-074b-4cf4-ab10-549e1ed09e2f2025-10-30WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEBryant Ranch Prepack7cef62ab-1740-4d0f-b6ea-fda783e1c1972025-10-23Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.002875d2-8c30-2d2e-e063-6294a90ae01e2025-10-22Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.66f0bf15-ff35-426a-b40c-0d0da79d08612025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.09ef39a4-c6b3-4395-8211-3f551dc448302025-10-16Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
IBUPROFEN AND FAMOTIDINEIBUPROFEN AND FAMOTIDINEPHOENIX RX LLC3ff33400-30e8-87fa-e063-6394a90a7f5c2025-10-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.5798d282-ce83-49aa-bc33-13203f2b52852025-10-15Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
acid reducer completeFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDESafeway4f0a178c-d0ed-4bbc-a8ce-fda3789d25f02025-10-14WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.2f5ec69d-926c-47a2-be47-8fef2e0ff2072025-10-14Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 284245
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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