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 2 of 19 · 362 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FamotidineFAMOTIDINEAdvanced Rx of Tennessee, LLC5648ca13-1add-56ec-e063-6294a90a6f292026-07-10Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Pepcid CompleteFAMOTIDINE, CALCIUM CARBONATE, AND MAGNESIUM HYDROXIDESelect Consumer Group55cc3304-9094-3da8-e063-6394a90aa49b2026-07-04WarningsExact identifier
unii: 5QZO15J2Z8
CareOne Acid ReliefFAMOTIDINEAmerican Sales Companyed474c9d-c08b-4f52-8b24-5887978e42752026-07-01WarningsExact identifier
unii: 5QZO15J2Z8
Goodmeds Famotidine 20mg 500 countFAMOTIDINE 20MGCabinet Health P.B.C.5592d0f0-03fd-c914-e063-6294a90a28262026-07-01WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINERedpharm Drug55730918-d9e8-eaad-e063-6394a90aeda22026-06-30Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 310273
unii: 5QZO15J2Z8
Zantac 360FAMOTIDINESelect Consumer Group LLC529cef2d-e6cc-3b37-e063-6294a90aff592026-06-27WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINESportpharm LLC4421ceb7-a114-436c-871a-7bc5444f81542026-06-26Warnings, Adverse reactionsExact identifier
rxcui: 284245
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINERISING PHARMA HOLDINGS, INC.c013654e-9cad-4c59-8fea-b00ae1567c182026-06-24Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINECVS Pharmacy, Inc.7357f67e-0fc6-4555-aa8b-1df09cba9feb2026-06-24WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEFamily Dollar Stores, LLC4dc7c2c4-83c7-608d-e063-6294a90a90eb2026-06-23WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEUnit Dose Solutions, Inc.54d93bf1-8f9a-981b-e063-6394a90a0fde2026-06-22Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Ibuprofen and FamotidineIBUPROFEN AND FAMOTIDINEAdvanced Rx of Tennessee, LLC548c705e-4094-fc6f-e063-6394a90a34262026-06-18Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINETWIN MED LLC795afb99-a3f4-4ffc-a905-2f84f3d86e4c2026-06-16WarningsExact identifier
unii: 5QZO15J2Z8
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINESafecor Health, LLC1b5cb132-d28f-4fbe-91f5-dc04f9a551d12026-06-11Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.e59a2c97-19c7-485c-bb1b-272ddb9ae0532026-06-09Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEPreferred Pharmaceuticals Inc.32fd4101-15cb-411e-8b9d-270ec0592c6e2026-06-08Warnings, Adverse reactionsExact identifier
rxcui: 310273
unii: 5QZO15J2Z8
FamotidineFAMOTIDINEST. MARY'S MEDICAL PARK PHARMACY31cdc900-fe17-2d5f-e063-6294a90a0fda2026-06-08Warnings, Adverse reactionsExact identifier
application number: ANDA215767
rxcui: 284245
unii: 5QZO15J2Z8
FamotidineFAMOTIDINESagent Pharmaceuticals9710995d-b518-40ce-bc2b-8b5dcf002c312026-06-06Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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