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 5 of 122 · 2,434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bare Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc552f20b2-9a2e-70f3-e063-6394a90a93372026-06-25WarningsExact identifier
unii: 15FIX9V2JP
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
unii: 1K09F3G675
BROAD SPECTRUM SPF 50 UNIVERSAL TINTED SUNSCREENTITANIUM DIOXIDEShantou Woodsleep Biotechnology Co., Ltd.54fc80b7-8f6c-e2be-e063-6394a90a4b592026-06-24WarningsExact identifier
unii: 15FIX9V2JP
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
application number: ANDA206531
rxcui: 199047
unii: 5QZO15J2Z8
Cerave Developed with Dermatologists Hydrating Sunscreen SPF 30 Body Lightweight, non-greasy feel 3 essential ceramides Mineral SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc54ecaea7-dafe-9694-e063-6394a90ae3b52026-06-23WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEFamily Dollar Stores, LLC4dc7c2c4-83c7-608d-e063-6294a90a90eb2026-06-23WarningsExact identifier
application number: ANDA206531
unii: 5QZO15J2Z8
RYDEEN UV CLEARSUNSCREENGuangzhou Oupeng Cosmetics Co., Ltd.548000cd-1655-aeb3-e063-6294a90ad0042026-06-22WarningsExact identifier
unii: 15FIX9V2JP
FamotidineFAMOTIDINEUnit Dose Solutions, Inc.54d93bf1-8f9a-981b-e063-6394a90a0fde2026-06-22Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Ibuprofen FamotidineIBUPROFEN FAMOTIDINEDirect_Rx54d9e1fc-507d-1859-e063-6394a90a8c6b2026-06-22Boxed warning, Warnings, Adverse reactionsExact identifier
unii: 5QZO15J2Z8
Good Instincts Proper Sunscreen SPF 50ZINC OXIDE, TITANIUM DIOXIDEInhabit Brands, Inc82d2af99-7c42-4ce5-94e0-b2ac60b8db1b2026-06-22WarningsExact identifier
unii: 15FIX9V2JP
ESPOIR BE VELVET COVER CUSHIONHOMOSALATE, TITANIUM DIOXIDEESPOIR Corporation54ce2420-4ac0-eb51-e063-6294a90a2de92026-06-21WarningsExact identifier
unii: 15FIX9V2JP
BABIES KIDSSUN PROTECTIONMINERAL SUNSCREENPANERGYTEK USA INC3a554118-b71d-a844-e063-6294a90a699f2026-06-20WarningsExact identifier
unii: 15FIX9V2JP
Creamy Beige Perfecting Makeup Broad Spectrum SPF 25OCTINOXATE, TITANIUM DIOXIDEMerle Norman Cosmetics, Inc548b7c90-ef97-38ab-e063-6394a90ac6092026-06-18WarningsExact identifier
unii: 15FIX9V2JP
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
rxcui: 199047
unii: 5QZO15J2Z8
FamotidineFAMOTIDINETWIN MED LLC6d97c60e-e39d-4541-ab49-d0fe3b3fa8402026-06-16WarningsExact identifier
unii: 5QZO15J2Z8
GlowBiotics Tinted Sunscreen SPF 30ZINC OXIDERum Brands, LLC544dba29-4785-4ab6-e063-6394a90a17b32026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe Prime and DefendZINC OXIDE SUNSCREENSociete Clinical Skincare5439bd31-5ee1-9bca-e063-6394a90a748c2026-06-16WarningsExact identifier
unii: 15FIX9V2JP
Societe CoverShield Tinted SPFZINC OXIDESociete Clinical Skincare545efbc4-82d4-f126-e063-6294a90a97102026-06-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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