FDA.reportPublic FDA data

NDC 80425-0384-01 - IBUPROFEN AND 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
80425-0384
Requested NDC
80425-0384-01
Package NDCs from labels
80425-0384-1, 80425-0384-2, 80425-0384-3, 80425-0384-01
Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC
Effective date
2024-04-23
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
IBUPROFEN AND FAMOTIDINE - Advanced Rx Pharmacy of Tennessee, LLCAdvanced Rx Pharmacy of Tennessee, LLC2024-04-23HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0384-1IBUPROFEN AND FAMOTIDINE30 in 1 BOTTLETABLET301
80425-0384-2IBUPROFEN AND FAMOTIDINE60 in 1 BOTTLETABLET601
80425-0384-3IBUPROFEN AND FAMOTIDINE90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0384IBUPROFEN AND FAMOTIDINE TABLET [ADVANCED RX PHARMACY OF TENNESSEE, LLC]1Current NDC, 3 package rows20240426_16c8b0db-37d0-99d9-e063-6394a90ac31b.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0384-1EA - Each80425-038476e60705-5101-43cb-8730-11d39c68e1f512024-06-10
80425-0384-2EA - Each80425-0384ccfa16aa-ab0a-4739-bb06-14b214400e2712024-06-10
80425-0384-3EA - Each80425-03844d802630-9552-417f-ab5b-8a83770799ef12024-06-10

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 8 of 123 · 2,441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PridICHTHAMMOL, CALCIUM SULFIDE, CALENDULA OFFICINALIS FLOWERING TOP, ARNICA MONTANA, ECHINACEA ANGUSTIFOLIA, SILICON DIOXIDE, SULFURHyland's Inc.49689eeb-7790-07f1-e063-6294a90a2df22026-07-16WarningsExact identifier
unii: ETJ7Z6XBU4
Curist Acid ReliefFAMOTIDINE 20 MGLittle Pharma, Inc.0fdfcc7c-aeed-6bd0-e063-6394a90ae52d2026-07-16WarningsExact identifier
unii: 5QZO15J2Z8
ibuprofenIBUPROFENHyVee Ince7175dc9-db39-4452-a419-85af179de4222026-07-16WarningsExact identifier
unii: WK2XYI10QM
ibuprofenIBUPROFENSun Pharmaceutical Industries, Inc.9de61620-6750-4fb6-89a4-fe451ab8d99f2026-07-15WarningsExact identifier
unii: WK2XYI10QM
Leg Cramps PMOYSTER SHELL CALCIUM CARBONATE, CRUDE, CAUSTICUM, MATRICARIA RECUTITA, CINCHONA OFFICINALIS BARK, COPPER, LYCOPODIUM CLAVATUM SPORE, MAGNESIUM PHOSPHATE, DIBASIC TRIHYDRATE, TOXICODENDRON PUBESCENS LEAF, SILICON DIOXIDE, AND SULFURHyland's Inc.b0574a7e-88fa-417e-b6d5-60ced59eba472026-07-15WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENStrides Pharma Science Limited38ebacc3-378f-483e-babc-76119677e7df2026-07-15Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBryant Ranch Prepackf1c88d74-09b0-4b14-baea-106fbbbc54bf2026-07-13Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
FAMOTIDINEFAMOTIDINEHAWAII REPACK, INC.eec89230-47fc-4139-a370-b4f9e225e8c02026-07-13Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
IbuprofenIBUPROFENCardinal Health 107, LLC0387bfaa-daca-48ec-b718-0216a848c16a2026-07-10Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENATLANTIC BIOLOGICALS CORP.3ce7549f-e4db-9f89-e063-6294a90a126d2026-07-10WarningsExact identifier
unii: WK2XYI10QM
Jacksons Cell Salts SILICA 12X 12SILICEAZettl Health Inc.5647dafc-1fff-6a25-e063-6294a90a8b4f2026-07-10Exact identifier
unii: ETJ7Z6XBU4
FamotidineFAMOTIDINEAdvanced Rx of Tennessee, LLC5648ca13-1add-56ec-e063-6294a90a6f292026-07-10Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
good sense ibuprofenIBUPROFENBryant Ranch Prepackd6460cc3-c207-44e0-bf78-ad6fef055ed52026-07-09WarningsExact identifier
unii: WK2XYI10QM
Freskaro Ear Drops for SwimmersFRESKARO EAR DROPS FOR SWIMMERSPharma Nobis, LLC4f724d85-cd38-41da-e063-6394a90a9fd72026-07-08WarningsExact identifier
unii: PDC6A3C0OX
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
unii: PDC6A3C0OX
IbuprofenIBUPROFENSt. Mary's Medical Park Pharmacy0a98cce4-f5c0-12a8-e063-6294a90a4e7e2026-07-07Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.b6a6c940-daf6-4e0e-aefb-35cce87a9a552026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENREMEDYREPACK INC.421156d2-85dc-4680-b2b4-d15b67539e872026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENBetter Living Brands, LLC45520969-7a2d-4469-ba25-7db160d50ccf2026-07-06WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPreferred Pharmaceuticals Inc.c0156053-add5-4bd5-b89f-f90df2e73be42026-07-06Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM

Reported adverse events (FAERS/openFDA)#

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