FDA.reportPublic FDA data

NDC 80425-0422-01 - 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
80425-0422
Requested NDC
80425-0422-01
Package NDCs from labels
80425-0422-3, 80425-0422-2, 80425-0422-1, 80425-0422-01
Manufacturer
Advanced Rx of Tennessee, LLC
Effective date
2024-07-16
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 of Tennessee, LLCAdvanced Rx of Tennessee, LLC2024-07-16HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80425-0422-1Ibuprofen and famotidine30 in 1 BOTTLETABLET, FILM COATED301
80425-0422-2Ibuprofen and famotidine60 in 1 BOTTLETABLET, FILM COATED601
80425-0422-3Ibuprofen and famotidine90 in 1 BOTTLETABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80425-0422IBUPROFEN AND FAMOTIDINE TABLET, FILM COATED [ADVANCED RX OF TENNESSEE, LLC]1Current NDC, 3 package rows20240718_1d625438-34dc-fbba-e063-6294a90afd2f.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
80425-0422-1EA - Each80425-04221aedba6a-263d-4cdd-91ec-2357650ba13f12024-08-12
80425-0422-2EA - Each80425-042226eb1409-447b-4a5a-8726-d35d7d92462b12024-08-12
80425-0422-3EA - Each80425-042206710e74-2eab-4557-bdea-af1b19f2474012024-08-12

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 214 · 4,264 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IbuprofenIBUPROFENShield Pharmaceuticals Corp216e5600-56b4-44b0-88b7-69adfb2458022026-08-06WarningsExact identifier
unii: WK2XYI10QM
EltaMD UV RestoreTITANIUM DIOXIDE, ZINC OXIDE SUNSCREENCP Skin Health Group, Inc37fee381-ce6b-4949-9a4a-778aa839fb842026-08-06WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENCOSTCO WHOLESALE CORPORATION4b8ad98e-de76-4f49-3b89-01e9dd5cde162026-08-06WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Companyd3d093f9-207a-40d4-a7be-c6b5a544a0a72026-08-06WarningsExact identifier
unii: WK2XYI10QM
ACID REDUCERFAMOTIDINECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf347f870-1da4-4a77-8c20-63b703d240712026-08-05WarningsExact identifier
unii: 5QZO15J2Z8
Leader Lubricant Eye Drops 30ctPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLCARDINAL HEALTH 110, LLC. DBA LEADER8df69f2c-40c4-245c-e053-2a95a90a54062026-08-05WarningsExact identifier
unii: 6DC9Q167V3
IbuprofenIBUPROFENP & L Development, LLC159b68b7-54e5-4f83-b632-f49e7b4b14a52026-08-05WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENWalgreen Companyc118b290-f821-4e73-906e-8a93edaf34e42026-08-05WarningsExact identifier
unii: WK2XYI10QM
Dye Free IbuprofenIBUPROFENWalgreen Company8944a0e8-2928-4494-915f-d1e0a6d4bf5c2026-08-04WarningsExact identifier
unii: WK2XYI10QM
ROROBELL WAWA Whitening ToothSILICA, HYDROGEN PEROXIDE, TOCOPHERYL ACETATEROROBELL58336a0d-49dd-ef13-e063-6394a90a38c12026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENREMEDYREPACK INC.560e4e05-21e0-4b2a-ab2f-872b5dbb39012026-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: WK2XYI10QM
Silicea 6XSILICON DIOXIDEHyland's Inc.db4be3c1-aa7e-24a2-e053-2a95a90a0c662026-08-04WarningsExact identifier
unii: ETJ7Z6XBU4
IbuprofenIBUPROFENChain Drug Marketing Association, Inc.733d0b21-c177-4c60-9243-2f1e7cb5854a2026-08-04WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC8abd74a4-ad33-4c10-b677-acb469f815e62026-08-03WarningsExact identifier
unii: WK2XYI10QM
IbuprofenIBUPROFENPioneer Life Sciences, LLC291602fa-8ebe-4200-bba7-9798c90f8a502026-08-03WarningsExact identifier
unii: WK2XYI10QM
Luxe Gloss Hydrating Lip Gloss SPF 35-NAKED HONEYOCTOCRYLENE 8%, OCTISALATE 5%, TITANIUM DIOXIDE 6%, ZINC OXIDE 8%Lale Cosmetics LLC581fb0cd-c55d-d562-e063-6394a90a7f112026-08-03WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENNUVICARE LLCb063d2dc-d579-46e7-8cfc-1596c803c7f92026-08-03WarningsExact identifier
unii: WK2XYI10QM
EltaMD UV ActiveZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc39d16479-d491-4c19-aa11-674461687c7b2026-08-03WarningsExact identifier
unii: 15FIX9V2JP
IbuprofenIBUPROFENNUVICARE LLC7905edc1-2a45-4adc-a7bc-42b1ddb6ba592026-08-03WarningsExact identifier
unii: WK2XYI10QM
Ibuprofen and famotidineIBUPROFEN AND FAMOTIDINEDoc Rx9f5de6af-e555-4efd-a3ed-b72c34c051b62026-08-01Boxed warning, Warnings, Adverse reactionsExact identifier
application number: ANDA211890
rxcui: 1100066
unii: WK2XYI10QM
unii: 5QZO15J2Z8

Reported adverse events (FAERS/openFDA)#

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