FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
60290-079
11-digit product format
602900079
Labeler code
60290
Product ID
60290-079_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
25 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 CITRATE25 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
60290-079-01SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED304
60290-079-02SILDENAFIL CITRATE90 in 1 BOTTLETABLET, FILM COATED904
60290-079-03SILDENAFIL CITRATE1000 in 1 BOTTLETABLET, FILM COATED10004
60290-079-04SILDENAFIL 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
60290-079-016029000790130 TABLET, FILM COATED in 1 BOTTLE (60290-079-01) 2026-02-15NoNoHistorical
60290-079-026029000790290 TABLET, FILM COATED in 1 BOTTLE (60290-079-02) 2026-02-15NoNoHistorical
60290-079-03602900079031000 TABLET, FILM COATED in 1 BOTTLE (60290-079-03) 2026-02-15NoNoHistorical
60290-079-0460290007904500 TABLET, FILM COATED in 1 BOTTLE (60290-079-04) 2026-04-27NoNoHistorical