FDA.reportPublic FDA data

NDC 35573-460-38 - tadalafil

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
35573-460
Requested NDC
35573-460-38
Package NDCs from labels
35573-460-38, 35573-460-56
Manufacturer
Burel Pharmaceuticals, LLC | VKT Pharma Private Limited
Effective date
2022-12-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
tadalafil - Burel Pharmaceuticals, LLC | VKT Pharma Private LimitedBurel Pharmaceuticals, LLC | VKT Pharma Private Limited2022-12-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35573-460-38tadalafil30 in 1 CARTONTABLET, FILM COATED304
35573-460-56tadalafil15 in 1 BLISTER PACKTABLET, FILM COATED154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-460TADALAFIL TABLET, FILM COATED [BUREL PHARMACEUTICALS, LLC]3Current NDC, 2 package rows20230401_a2e7f393-5cfc-45e5-b87d-9e8abc8e4355.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-460-38EA - Each35573-46081bf747e-b15f-452b-8ece-319074dab7ee12023-05-05
35573-460-56EA - Each35573-460e5c9e3df-160f-497f-8ddd-a75c60593e7512023-05-05

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 111 · 2,204 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TadalafilTADALAFILA-S Medication Solutionsb1840f16-a7ea-44bd-b091-5268990aedb22026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 402019
unii: 742SXX0ICT
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30W Aesthetics5b0f2c8f-d6fa-5e25-e063-6394a90a084d2026-09-09WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILA-S Medication Solutions81222924-29d9-4031-954d-132923867b8e2026-09-09Warnings, Adverse reactionsExact identifier
rxcui: 402019
unii: 742SXX0ICT
TadalafilTADALAFILA-S Medication Solutionscf9431ef-ea02-457d-b83a-ce13fb963d952026-08-28Warnings, Adverse reactionsExact identifier
rxcui: 402019
unii: 742SXX0ICT
MZANK SUNSCREEN DAILY ULTIMATE PROTECTION SPF50SUNSCREEN SPF50Guangzhou Meixi Biotechnology Co., Ltd.5a0b4bd2-f6ad-35dc-e063-6294a90a8a662026-08-27WarningsExact identifier
unii: 15FIX9V2JP
tadalafilTADALAFILBryant Ranch Prepack394be6ef-c0f7-4cd5-8062-39fda5c1c2c42026-08-27Warnings, Adverse reactionsExact identifier
rxcui: 484814
unii: 742SXX0ICT
MELAO Hydrating Lightweight SunscreenAVOBENZONE,ENSULIZOLE,HOMOSALATE,OCTISALATE,OCTOCRYLENE,TITANIUM DIOXIDEGuangdong Aimu Biological Technology Co., Ltd59eeaea1-d726-99f3-e063-6394a90aeea32026-08-26WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILA-S Medication Solutionsa6847ad6-3b5b-47e5-a3b5-04dc3182d72b2026-08-25Warnings, Adverse reactionsExact identifier
rxcui: 402019
unii: 742SXX0ICT
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
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
Rohto All-In-OneHYPROMELLOSE, TETRAHYDROZOLINE HYDROCHLORIDE, ZINC SULFATEThe Mentholatum Company43e690e4-b381-46e3-838c-33aef5bdadde2026-08-20WarningsExact identifier
unii: 3NXW29V3WO
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: 15FIX9V2JP
TadalafilTADALAFILNuCare Pharmaceuticals,Inc.c3409762-3b2b-1cfc-e053-2995a90ab91b2026-08-18Warnings, Adverse reactionsExact identifier
rxcui: 402019
unii: 742SXX0ICT
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
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30CORBY, JR., TERRY L.594443fd-8e27-4ec6-e063-6294a90a3ff02026-08-17WarningsExact identifier
unii: 15FIX9V2JP
Leader Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400CARDINAL HEALTH 110, LLC. DBA LEADER2ded4bda-b3c3-4521-8701-5c8446fd148b2026-08-17WarningsExact identifier
unii: 3NXW29V3WO

Reported adverse events (FAERS/openFDA)#

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