SILDENAFIL CITRATE

Product NDC
68788-4111
11-digit product format
687884111
Labeler code
68788
Product ID
68788-4111_5f9ff0bb-5634-437a-96eb-249b910c7e81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA091448
Marketing category
ANDA
Marketing start
2026-04-22
Substance
SILDENAFIL CITRATE
Active strength
100 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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
68788-4111-1SILDENAFIL CITRATE10 in 1 BOTTLETABLET, FILM COATED101
68788-4111-3SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED301
68788-4111-7SILDENAFIL CITRATE7 in 1 BOTTLETABLET, FILM COATED71

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN5f9ff0bb-5634-437a-96eb-249b910c7e811
314229sildenafil 100 MG Oral TabletSCD5f9ff0bb-5634-437a-96eb-249b910c7e811
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5f9ff0bb-5634-437a-96eb-249b910c7e811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68788-4111-16878841110110 TABLET, FILM COATED in 1 BOTTLE (68788-4111-1) 2026-04-22NoNoHistorical
68788-4111-36878841110330 TABLET, FILM COATED in 1 BOTTLE (68788-4111-3) 2026-04-22NoNoHistorical
68788-4111-7687884111077 TABLET, FILM COATED in 1 BOTTLE (68788-4111-7) 2026-04-22NoNoHistorical