FDA.reportPublic FDA data

Sildenafil

Product NDC
59762-2058
Requested package NDC
59762-2058-1
11-digit product format
597622058
Labeler code
59762
Product ID
59762-2058_8f234077-0221-4a20-b115-23a9f061a402
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Greenstone LLC
Application
NDA203109
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2019-09-11
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
10 mg/mL
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage59762-205859762-2058-1DDiscontinued by firm2026-08-03
excluded packagepackage59762-205859762-2058-1DDiscontinued by firm2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N203109-001REVATIOSILDENAFIL CITRATEEQ 10MG BASE/MLFOR SUSPENSION / ORALRLD2012-08-30

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N203109-001M-2872026-01-31

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06N203109-001REVATIOEQ 10MG BASE/MLFOR SUSPENSION / ORALRLD2012-08-30a50c72e98297…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2026-08-01 22:54:322026-06N203109-001M-2872026-01-31a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RevatioSILDENAFIL CITRATEViatris Specialty LLC3bb9363e-b28d-4019-8aae-539233dca2142024-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 203109
application number: NDA203109

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59762-2058-1Sildenafil1 in 1 CARTONPOWDER, FOR SUSPENSION119
59762-2058-1Sildenafil112 mL in 1 BOTTLEPOWDER, FOR SUSPENSION11219

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-2058-1ML - Milliliter59762-2058c093b6fd-e0fc-4678-b31e-6079ed7ddffd12019-10-07

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5XSILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [GREENSTONE LLC]9

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-2058SILDENAFIL TABLET, FILM COATED SILDENAFIL POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.]19Legacy NDC, 2 package rows20250503_56a962e8-de00-4a97-8904-0b1bd217dd83.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN56a962e8-de00-4a97-8904-0b1bd217dd8319
577033sildenafil citrate 20 MG Oral TabletPSN56a962e8-de00-4a97-8904-0b1bd217dd8319
1307427sildenafil 10 MG/ML Oral SuspensionSCD56a962e8-de00-4a97-8904-0b1bd217dd8319
577033sildenafil 20 MG Oral TabletSCD56a962e8-de00-4a97-8904-0b1bd217dd8319
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY56a962e8-de00-4a97-8904-0b1bd217dd8319
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY56a962e8-de00-4a97-8904-0b1bd217dd8319
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY56a962e8-de00-4a97-8904-0b1bd217dd8319

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59762-2058-1597622058011 BOTTLE in 1 CARTON (59762-2058-1) > 112 mL in 1 BOTTLE1 bottle2019-09-110000-00-00NoNoCurrent