FDA.reportPublic FDA data

Sildenafil

Product NDC
59762-0033
11-digit product format
597620033
Labeler code
59762
Product ID
59762-0033_c1cc0357-ac81-40b6-a401-dfd941495be5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA021845
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2012-09-27
Marketing end
2026-07-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033, 1307427

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
59762-0033-1Sildenafil90 in 1 BOTTLETABLET, FILM COATED9019
59762-0033-3Sildenafil300 in 1 BOTTLETABLET, FILM COATED30019

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0033-1EA - Each59762-00336774514d-b798-4e58-8f10-209fea47ee7412013-02-13

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
59762-0033SILDENAFIL TABLET, FILM COATED SILDENAFIL POWDER, FOR SUSPENSION [MYLAN PHARMACEUTICALS INC.]19Current NDC, Legacy 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
577033sildenafil citrate 20 MG Oral TabletPSNf2abd969-5ff1-413b-80ab-5e39391168773
577033sildenafil 20 MG Oral TabletSCDf2abd969-5ff1-413b-80ab-5e39391168773
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf2abd969-5ff1-413b-80ab-5e39391168773
577033sildenafil citrate 20 MG Oral TabletPSNe1164415-0fe0-409f-b2b2-5c34bc36b51a2
577033sildenafil 20 MG Oral TabletSCDe1164415-0fe0-409f-b2b2-5c34bc36b51a2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe1164415-0fe0-409f-b2b2-5c34bc36b51a2
577033sildenafil citrate 20 MG Oral TabletPSN761f9606-2583-439a-a29e-736008340a9e1
577033sildenafil 20 MG Oral TabletSCD761f9606-2583-439a-a29e-736008340a9e1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY761f9606-2583-439a-a29e-736008340a9e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0033-15976200330190 TABLET, FILM COATED in 1 BOTTLE (59762-0033-1) 2012-09-270000-00-00NoNoCurrent
59762-0033-359762003303300 TABLET, FILM COATED in 1 BOTTLE (59762-0033-3) 2020-11-092026-07-31NoNoCurrent