FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
60290-002
11-digit product format
602900002
Labeler code
60290
Product ID
60290-002_51b76a30-43fd-eaa4-e063-6394a90a286d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Umedica Laboratories USA Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2026-02-15
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SILDENAFIL CITRATE
Listing expiration
2027-12-31

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60290-002-012019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
60290-002-022019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998
60290-002-032019-11-27C16284748780-19855e2a2-3f7e-60a7-e053-dbdaa90a05bdThese highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. SILDENAFIL tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60290-002-01SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED304
60290-002-02SILDENAFIL CITRATE100 in 1 BOTTLETABLET, FILM COATED1004
60290-002-03SILDENAFIL CITRATE1000 in 1 BOTTLETABLET, FILM COATED10004
60290-002-04SILDENAFIL CITRATE500 in 1 BOTTLETABLET, FILM COATED5004

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil citrate 25 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil citrate 50 MG Oral TabletPSN90477a51-63ba-43f4-a74b-4659a946093c4
314229sildenafil 100 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil 25 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil 50 MG Oral TabletSCD90477a51-63ba-43f4-a74b-4659a946093c4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY90477a51-63ba-43f4-a74b-4659a946093c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60290-002-016029000020130 TABLET, FILM COATED in 1 BOTTLE (60290-002-01) 2026-02-15NoNoHistorical
60290-002-0260290000202100 TABLET, FILM COATED in 1 BOTTLE (60290-002-02) 2026-02-15NoNoHistorical
60290-002-03602900002031000 TABLET, FILM COATED in 1 BOTTLE (60290-002-03) 2026-02-15NoNoHistorical
60290-002-0460290000204500 TABLET, FILM COATED in 1 BOTTLE (60290-002-04) 2026-02-15NoNoHistorical