FDA.reportPublic FDA data

NDC 58602-705-03 - 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
58602-705
Requested NDC
58602-705-03
Package NDCs from labels
58602-705-15, 58602-705-19, 58602-705-84, 58602-705-03, 58602-705-09, 58602-705-12, 58602-705-93, 58602-705-14, 58602-705-34, 58602-705-39, 58602-705-44, 58602-705-40, 58602-705-88, 58602-705-41, 58602-705-32
Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED
Effective date
2025-03-15
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Famotidine - Aurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITEDAurohealth LLC | Aurobindo Pharma Limited | APL HEALTHCARE LIMITED2025-03-15Human OTC Drug Label
Famotidine - Proficient Rx LPProficient Rx LP2022-06-01HUMAN OTC DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-705-03Famotidine10 in 1 BLISTER PACKTABLET, FILM COATED1013
58602-705-09Famotidine3 in 1 CARTONTABLET, FILM COATED313
58602-705-12Famotidine4 in 1 CARTONTABLET, FILM COATED413
58602-705-14Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-14Famotidine50 in 1 BOTTLETABLET, FILM COATED5013
58602-705-15Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-15Famotidine60 in 1 BOTTLETABLET, FILM COATED6013
58602-705-19Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-19Famotidine90 in 1 BOTTLETABLET, FILM COATED9013
58602-705-32Famotidine180 in 1 BOTTLETABLET, FILM COATED18013
58602-705-32Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-34Famotidine200 in 1 BOTTLETABLET, FILM COATED20013
58602-705-39Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-39Famotidine365 in 1 BOTTLETABLET, FILM COATED36513
58602-705-40Famotidine500 in 1 BOTTLETABLET, FILM COATED50013
58602-705-40Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-41Famotidine1000 in 1 BOTTLETABLET, FILM COATED100013
58602-705-41Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-44Famotidine400 in 1 BOTTLETABLET, FILM COATED40013
58602-705-84Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-84Famotidine30 in 1 BOTTLETABLET, FILM COATED3013
58602-705-88Famotidine750 in 1 BOTTLETABLET, FILM COATED75013
58602-705-88Famotidine1 in 1 CARTONTABLET, FILM COATED113
58602-705-93Famotidine90 in 1 BOTTLETABLET, FILM COATED9013

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58602-705FAMOTIDINE TABLET, FILM COATED [AUROHEALTH LLC]13Current NDC, Legacy NDC, 26 package rows20250321_756c7234-6a63-4b1b-be36-2b1ed09e67a0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
58602-705-15EA - Each58602-705f2623aa0-791a-40af-ac34-8254bc52f7c912022-02-07
58602-705-19EA - Each58602-7056402435b-39ad-40bf-aadd-6feba559e09812021-04-08
58602-705-84EA - Each58602-70571d62bb7-0854-4a7b-9efa-f26c2d6522d612020-07-13

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 123 · 2,454 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEREMEDYREPACK INC.669fbd46-cae5-4477-884e-8eca893d2e052026-09-09Warnings, Adverse reactionsExact identifier
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
application number: ANDA206531
unii: 5QZO15J2Z8
CalamineCALAMINE, PRAMOXINE HCLUnited Natural Foods, Inc. dba UNFI0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea2026-09-04Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
ACID REDUCERFAMOTIDINEAmazon.com Services LLCd5823283-aa97-451e-ba0d-69f0e79c85142026-08-31WarningsExact identifier
rxcui: 199047
unii: 5QZO15J2Z8
CalamineFERRIC OXIDE REDYour Military Exchangesaf95a66c-f063-4019-80c6-6f7dc4fee4d82026-08-28Warnings, Adverse reactionsExact identifier
unii: 1K09F3G675
FAMOTIDINEFAMOTIDINEREMEDYREPACK INC.9c5dce17-1865-4aa6-89f6-24dd55b5f06c2026-08-27Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
Calamine PlusCALAMINE, PRAMOXINE HYDROCHLORIDEKroger Company44fdd5a4-3cac-15e5-e063-6294a90adb522026-08-26WarningsExact identifier
unii: 1K09F3G675
Pepcid Complete Dual Action Berry FlavorFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDEJones Healthcare Group - Packaging Services, Incfff07b68-02ca-438e-8d53-5b4edf5eefc52026-08-25WarningsExact identifier
unii: 5QZO15J2Z8
Q Skin ScienceSUNSCREENInternational Cosmeceuticals, Inc59e4c3d0-ee4c-2350-e063-6394a90ac9d22026-08-25WarningsExact identifier
unii: 15FIX9V2JP
MELAO zinc stick(GREEN)TITANIUM DIOXIDE,ZINC OXIDE,OCTOCRYLENEGuangzhou Haishi Biological Technology Co., Ltd.59c70c82-f7ff-9a04-e063-6294a90a7b3d2026-08-24WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEPD-Rx Pharmaceuticals, Inc.599642c8-51cd-4220-e063-6394a90a5e202026-08-24Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: 15FIX9V2JP
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEMajor Pharmaceuticals3e6d167f-91e4-4122-911d-d3da66386f442026-08-20Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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