FDA.reportPublic FDA data

NDC 58151-385-35 - Revatio

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
58151-385
Requested NDC
58151-385-35
Package NDCs from labels
58151-385-35
Manufacturer
Viatris Specialty LLC
Effective date
2024-12-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Revatio - Viatris Specialty LLCViatris Specialty LLC2024-12-18HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58151-385-35Revatio1 in 1 CARTONPOWDER, FOR SUSPENSION14
58151-385-35Revatio112 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION1124

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58151-385REVATIO (SILDENAFIL CITRATE) TABLET, FILM COATED REVATIO (SILDENAFIL CITRATE) INJECTION, SOLUTION REVATIO (SILDENAFIL CITRATE) POWDER, FOR SUSPENSION [VIATRIS SPECIALTY LLC]3Current NDC, 2 package rows20250410_3bb9363e-b28d-4019-8aae-539233dca214.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 92 of 154 · 3,068 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil Sheer Mineral Sunscreen Stick SPF 50TITANIUM DIOXIDE, ZINC OXIDEGalderma Laboratories, L.P.54f6df65-e90c-4070-aa95-f47496dd11bd2025-01-27WarningsExact identifier
unii: 15FIX9V2JP
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: ETJ7Z6XBU4
Sodium Citrate w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltdc9d0e9c8-379f-4895-b272-329efab575c42025-01-24Warnings, Adverse reactionsExact identifier
unii: B22547B95K
CoTZ Silky Foam - TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTDd63088d7-a1d7-4b56-a7d8-ad217011a8a82025-01-24WarningsExact identifier
unii: 15FIX9V2JP
CoTZ Silky Foam Non-TintedTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD9c04b76e-ae65-4183-b475-3b8e8764db592025-01-24WarningsExact identifier
unii: 15FIX9V2JP
SildenafilSILDENAFILModavar Pharmaceuticals LLC8c4f22c8-3607-4d64-8821-dd3202f8fa0a2025-01-23Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Sodium Citrate 4% w/v AnticoagulantTRISODIUM CITRATE DIHYDRATETerumo BCT, Ltd0775912f-f14a-4967-ac00-c8c1b36040bf2025-01-23Warnings, Adverse reactionsExact identifier
unii: B22547B95K
SildenafilSILDENAFILCadila Pharmaceuticals Limitedc079fc41-7b9a-499d-88ea-86ccb65c828d2025-01-23Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
DOCTRUST K ToothSILICON DIOXIDE, SODIUM MONOFLUOROPHOSPHATEDOCSMEDI Co., Ltd.a02f8865-e7be-4ef4-b09c-dad8466397642025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
Lemon QuinceLEMON QUINCEUriel Pharmacy Inc332e4a40-e0f3-11de-8a39-0800200c9a662025-01-22WarningsExact identifier
unii: ETJ7Z6XBU4
SILDENAFILSILDENAFILDirectRxd1ee9139-13ac-7d5b-e053-2995a90a8e502025-01-20Warnings, Adverse reactionsExact identifier
rxcui: 577033
unii: BW9B0ZE037
SILDENAFIL CITRATESILDENAFIL CITRATEPreferred Pharmaceuticals Inc.5846bff2-6a93-46a7-a547-04459c5908142025-01-20Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Medics Choice Soothing Eye WashPURIFIED WATERKC Pharmaceuticals, Inc.10e49808-161e-f4ec-e063-6294a90a17752025-01-19WarningsExact identifier
unii: 059QF0KO0R
SILDENAFILSILDENAFILDIRECT RXa84a418a-155c-7be7-e053-2995a90a81582025-01-17Warnings, Adverse reactionsExact identifier
unii: BW9B0ZE037
Proceuticals Private Label by TiZO Tinted Facial Mineral Sunscreen BackbarTITANIUM DIOXIDE, ZINC OXIDEFallien Cosmeceuticals, LTD2be9f92a-a041-0595-e063-6394a90af7a82025-01-17WarningsExact identifier
unii: 15FIX9V2JP
Hydration ComplexBETA VULGARIS, BOLDO, CALCAREA FLUORICA, CALCAREA PHOSPHORICA, CARDUUS BENEDICTUS, CHELIDONIUM MAJUS, COFFEA TOSTA, EQUISETUM ARVENSE, GERMANIUM SESQUIOXIDE, GINKGO BILOBA, HYPERICUM PERFORATUM, KALI MURIATICUM, KALI PHOSPHORICUM, KALI SULPHURICUM, PETROSELINUM SATIVUM, SILICEA, TARAXACUM OFFICINALEDeseret Biologicals, Inc.f60a2ab8-4146-4995-9bc6-be2660b175402025-01-16WarningsExact identifier
unii: ETJ7Z6XBU4
HUTTON KLEIN HK DERMATOLOGISTS SPF 40 Mineral Based Facial Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEHutton, Kathleen MD293a6a6c-adf3-452d-92f5-3baceb619e392025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 020OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior594982d5-b4bf-4889-99b7-b3cd58fa80312025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 010OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dior26f1dcde-209e-4c6d-9577-1f3d3e21595f2025-01-16WarningsExact identifier
unii: 15FIX9V2JP
CAPTURE DREAMSKIN FRESH AND PERFECT CUSHION WITH SUNSCREEN BROAD SPECTRUM SPF 50 000OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDEParfums Christian Dioradba288c-e94f-4b26-8f7d-336f3e5108bd2025-01-16WarningsExact identifier
unii: 15FIX9V2JP

Reported adverse events (FAERS/openFDA)#

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