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 89 of 110 · 2,187 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Natural Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDESarati International, Inc.16ef922d-78d1-1e70-e063-6394a90a3bbf2024-04-25WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AlabasterTITANIUM DIOXIDEChantecaille Beaute Ince1c562b8-76c0-4c6e-9276-900784c8639e2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 WheatTITANIUM DIOXIDEChantecaille Beaute Inc89f19f7a-60e3-4080-a49a-a4eb3e6c27de2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 AuraTITANIUM DIOXIDEChantecaille Beaute Incde441a6c-55e3-4b11-afb3-d7db3c6971f02024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 BlissTITANIUM DIOXIDEChantecaille Beaute Inc16d9e226-7694-922a-e063-6394a90aea852024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 GlowTITANIUM DIOXIDEChantecaille Beaute Incf868fe4f-4c10-4f0f-9f1d-008f067744082024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 NudeTITANIUM DIOXIDEChantecaille Beaute Inccb8feddc-ae98-42ea-ad1e-583dcacfa5d92024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 OpalineTITANIUM DIOXIDEChantecaille Beaute Inc1c918b4b-763b-48bf-9ae3-661eabafee162024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TanTITANIUM DIOXIDEChantecaille Beaute Incfdf05545-5a21-4238-b0d3-e3fcdfe866ff2024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 TopazTITANIUM DIOXIDEChantecaille Beaute Inc2012f671-7889-4e29-b70f-215cbc9dbdc72024-04-24WarningsExact identifier
unii: 15FIX9V2JP
Chantecaille Just Skin Tinted Moisturizer Sunscreen Broad Spectrum SPF 15 VanillaTITANIUM DIOXIDEChantecaille Beaute Inc7133c47d-ed1c-43e9-8cdf-42f7b2f215f52024-04-24WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILAmneal Pharmaceuticals of New York LLCa0b734f4-9347-484d-b307-d493ae50ee542024-04-23Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
SPF30 Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC37d696d9-f89d-498e-8fe9-1f08d05d7b612024-04-18WarningsExact identifier
unii: 15FIX9V2JP
Cetaphil Daily Facial Moisturizer with suncreen SPF 50OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE, TITANIUM DIOXIDEGalderma Laboratories, L.P.6650d137-e69e-4ec2-8311-3de74bf213152024-04-17WarningsExact identifier
unii: 15FIX9V2JP
SPF 30 Mineral Sunscreen CariposaTITANIUM DIOXIDE, ZINC OXIDETalent Brands Company LLC0bc21573-d302-4d85-8d8f-dca9a48e1f352024-04-17WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILCamber Pharmaceuticals, Inc.f9415142-a5ac-45c0-a7c2-fb1fb6751f3d2024-04-12Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
RV Illuminance Serum Tint Broad Spectrum 15FACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp132aab60-da19-7079-e063-6394a90a1d762024-03-27WarningsExact identifier
unii: 15FIX9V2JP
RV Illuminance Serum Tint Broad Spectrum 15 AmberFACE FOUNDATION WITH SPFREVLON CONSUMER PR Consumer Products Corp2a0ac71c-e53a-5ff9-e063-6394a90a48072024-03-27WarningsExact identifier
unii: 15FIX9V2JP
EltaMD UV Pure SPF47ZINC OXIDE AND TITANIUM DIOXIDE SUNSCREENCP Skin Health Group, Inc.9afe900b-4186-4189-a871-ad6f26fc26e42024-03-27WarningsExact identifier
unii: 15FIX9V2JP
SPF 50 Mineral Based Facial SunscreenTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD5cf0d2e3-d496-424c-ac75-70ff5b87e9ca2024-03-25WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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