FDA.reportPublic FDA data

NDC 80425-0329-03 - 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
80425-0329-03
Package NDCs from labels
80425-0329-1, 80425-0329-2, 80425-0329-3, 80425-0329-03
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 1 of 19 · 369 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEREMEDYREPACK INC.669fbd46-cae5-4477-884e-8eca893d2e052026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb023cd92-eabb-474b-9b5a-4b46cf48256b2026-09-08WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAurohealth LLC5b161f25-c578-4ff4-a931-ff3a1e681c502026-09-04WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINEAmazon.com Services LLCd5823283-aa97-451e-ba0d-69f0e79c85142026-08-31WarningsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
Pepcid Complete Dual Action Berry FlavorFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJones Healthcare Group - Packaging Services, Incfff07b68-02ca-438e-8d53-5b4edf5eefc52026-08-25WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.599642c8-51cd-4220-e063-6394a90a5e202026-08-24Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 284245
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEMajor Pharmaceuticals3e6d167f-91e4-4122-911d-d3da66386f442026-08-20Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.cd95271c-cf39-47fb-97a6-f6ee1e619e4a2026-08-12Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
heartburn preventionFAMOTIDINEKroger Companyc97851ef-7b49-4f6c-b165-147555db101a2026-08-11WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED7e5f9492-1d58-47a3-aac6-c41c81b348d52026-08-03WarningsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEPD-Rx Pharmaceuticals, Inc.a0f38398-4d34-4ecc-8a6a-37732adaaad32026-07-30Warnings, Adverse reactionsExact identifier
rxcui: 284245
unii: 5QZO15J2Z8
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEAscend Laboratories, LLC4493d4cd-ca8e-4b0a-9b65-b75e55bf8b9e2026-07-28Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
DUAL ACTION COMPLETEFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDEAmazon.com Services LLC4e8a936c-b876-4923-ad9e-d23537b5d7cf2026-07-28WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEAscend Laboratories, LLCb2228be0-472b-4e47-9910-af0bf12fde772026-07-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDEKenvue Brands LLCa2ef8424-7d80-42b0-a01e-f378f629b2b62026-07-24WarningsExact identifier
unii: 5QZO15J2Z8
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE AND MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED962ced24-0fb3-4aba-b32e-2e6fa1c1c5d72026-07-22WarningsExact identifier
unii: 5QZO15J2Z8
Curist Acid ReliefFAMOTIDINE 20 MGLittle Pharma, Inc.0fdfcc7c-aeed-6bd0-e063-6394a90ae52d2026-07-16WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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