FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
59762-0035
11-digit product format
597620035
Labeler code
59762
Product ID
59762-0035_6b8ead94-5df8-4fbd-a75e-388f8147fe5d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Mylan Pharmaceuticals Inc.
Application
NDA020895
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-12-01
Substance
SILDENAFIL CITRATE
Active strength
50 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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
59762-0035-1Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED3010
59762-0035-2Sildenafil Citrate100 in 1 BOTTLETABLET, FILM COATED10010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59762-0035-1EA - Each59762-003503aee897-9244-4f05-b360-fa035e511f1812018-01-12
59762-0035-2EA - Each59762-0035467e1e3c-c02f-44db-9acc-e376a055f75812018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59762-0035SILDENAFIL CITRATE TABLET, FILM COATED [MYLAN PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 2 package rows20250504_98a9897b-0cbc-4ea6-9ac2-4dd719a2ede0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil citrate 25 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil citrate 50 MG Oral TabletPSN98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314229sildenafil 100 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil 25 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil 50 MG Oral TabletSCD98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY98a9897b-0cbc-4ea6-9ac2-4dd719a2ede010
314229sildenafil citrate 100 MG Oral TabletPSN7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil citrate 50 MG Oral TabletPSN7c3798c1-7884-4943-a59e-079524e125124
314229sildenafil 100 MG Oral TabletSCD7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil 50 MG Oral TabletSCD7c3798c1-7884-4943-a59e-079524e125124
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY7c3798c1-7884-4943-a59e-079524e125124
312950sildenafil citrate 50 MG Oral TabletPSN7a4c81f9-826b-4d36-adc9-e6d8a839845e2
312950sildenafil 50 MG Oral TabletSCD7a4c81f9-826b-4d36-adc9-e6d8a839845e2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY7a4c81f9-826b-4d36-adc9-e6d8a839845e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
59762-0035-15976200350130 TABLET, FILM COATED in 1 BOTTLE (59762-0035-1) 2017-12-012026-10-31NoNoCurrent
59762-0035-259762003502100 TABLET, FILM COATED in 1 BOTTLE (59762-0035-2) 2017-12-010000-00-00NoNoCurrent