FDA.reportPublic FDA data

NDC 68071-4599-01 - Sildenafil

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
68071-4599
Requested NDC
68071-4599-01
Package NDCs from labels
68071-4599-1, 68071-4599-5, 68071-4599-9, 68071-4599-01
Manufacturer
NuCare Pharmaceuticals,Inc.
Effective date
2024-06-12
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Sildenafil - NuCare Pharmaceuticals,Inc.NuCare Pharmaceuticals,Inc.2024-06-12HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-4599-12021-02-22C16284748780-1ba0f9c33-10bd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
68071-4599-12021-01-29C16284748780-1ba0f9c33-10bd-a910-e053-dadaa90a0b85These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4599-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED107
68071-4599-5Sildenafil15 in 1 BOTTLETABLET, FILM COATED157
68071-4599-9Sildenafil90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4599SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]7Current NDC, Legacy NDC, 3 package rows20240614_78101030-ef1d-44b9-e053-2991aa0a158d.zip

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 82 of 110 · 2,187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3WOOCTISALATE, TITANIUM DIOXIDEParfums Christian Diorf5a006d1-e957-4063-9b45-2874a1445a332024-11-11WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 2WPOCTISALATE, TITANIUM DIOXIDEParfums Christian Dior6943a531-c4e7-4e98-9970-3a30b9681b7b2024-11-11WarningsExact identifier
unii: 15FIX9V2JP
FOREVER SKIN GLOW 24h wear radiant foundation Perfection and hydration Concentrated floral skincare with suncreen Broad spectrum SPF 15 3.5NOCTISALATE, TITANIUM DIOXIDEParfums Christian Diora74102d3-b535-4419-8e21-e961980e489d2024-11-11WarningsExact identifier
unii: 15FIX9V2JP
INTRAL SENSITIVE SKIN ENVIRONMENTAL LIGHTWEIGHT SHIELD BROAD SPECTRUM SPF50TITANIUM DIOXIDE AND ZINC OXIDEDARPHIN DIST.91277514-4db0-4b40-b95a-3530cac711df2024-11-11WarningsExact identifier
unii: 15FIX9V2JP
DAILY LIGHT GUARD DEFENSE FLUID BROAD SPECTRUM SPF 30TITANIUM DIOXIDE AND ZINC OXIDEAveda Corporationdfa84bcc-a9b4-426d-8733-35f58c40e94d2024-11-11WarningsExact identifier
unii: 15FIX9V2JP
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYfef47045-1d3c-4f08-acec-e96abefbc2612024-11-08WarningsExact identifier
unii: 15FIX9V2JP
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY547388c6-378b-488b-89d1-c77ebc5d2ed82024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 SUMMER BLEND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY9641b71a-81f2-4157-801b-162188392a912024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 SUPER SENSITIVE SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd79cf2d9-4923-452a-bb44-67e059ee37ee2024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 EVERYDAY/YEAR-ROUND SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTYd4f30d95-4a3f-49ad-817e-faa86fca50182024-11-07WarningsExact identifier
unii: 15FIX9V2JP
SPF30 CALENDULA SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY64580be7-868c-40fb-b7b8-840b417b25d32024-11-06WarningsExact identifier
unii: 15FIX9V2JP
KIDS SPF30 SUPER SENSITIVE PLUS C111 SUNSCREENTITANIUM DIOXIDEORGANIC & SUSTAINABLE BEAUTY20ebe264-2f79-4eef-b83d-3f09a3ca28982024-11-06WarningsExact identifier
unii: 15FIX9V2JP
Cream Oil SunscreenZINC OXIDE, TITANIUM DIOXIDE SUNSCREENOwen Biosciences, Inc.b2ccdfea-1c27-42af-b9d8-752e9f91ae872024-11-05WarningsExact identifier
unii: 15FIX9V2JP
AddiclenzBOLDO, CARDUUS MARIANUS, CHELIDONIUM MAJUS, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, ARSENICUM ALBUM, BISPHENOL A, COBALTUM METALLICUM, CUPRUM METALLICUM, GLYPHOSATE, IODIUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, SELENIUM METALLICUM, ZINCUM METALLICUM, ASPARTAME, BENZALKONIUM CHLORIDE, FORMALINUM, METHYLENE CHLORIDE, METHYL PARABEN, PROPYL PARABEN, SODIUM BENZOATE, SODIUM CITRATE, TITANIUM DIOXIDE, ZINCUM OXYDATUMDeseret Biologicals, Inc.8a3b75ca-8fec-4318-8a55-8bde0b82637d2024-10-31WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILBryant Ranch Prepackf9ab796c-1912-4137-abec-e8336a850a582024-10-31Warnings, Adverse reactionsExact identifier
rxcui: 314229
unii: BW9B0ZE037
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDEZO Skin Health, Inc.9a4f5be1-da04-48b9-897a-57f4a3d9d1ec2024-10-29WarningsExact identifier
unii: 15FIX9V2JP
ZO Skin Health Broad-Spectrum Sunscreen SPF 50TITANIUM DIOXIDE, ZINC OXIDEZO Skin Health, Inc.d817f80b-a998-b67e-e053-2995a90a19712024-10-29WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Kids Mineral Protection SPF50TITANIUM DIOXIDE,ZINC OXIDEEdgewell Personal Care Brands LLCdc7701b5-0c73-b4df-e053-2a95a90a0f1b2024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive SPF 50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc7913d5-58f2-3077-e053-2a95a90a16272024-10-27WarningsExact identifier
unii: 15FIX9V2JP
Banana Boat Mineral Sensitive Face SPF50TITANIUM DIOXIDE, ZINC OXIDEEdgewell Personal Care Brands LLCdc783438-b28f-b7f4-e053-2a95a90a3d652024-10-27WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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