FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
68788-8804
11-digit product format
687888804
Labeler code
68788
Product ID
68788-8804_5846bff2-6a93-46a7-a547-04459c590814
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2025-01-20
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
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 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
68788-8804-1SILDENAFIL CITRATE10 in 1 BOTTLETABLET101
68788-8804-3SILDENAFIL CITRATE30 in 1 BOTTLETABLET301
68788-8804-7SILDENAFIL CITRATE7 in 1 BOTTLETABLET71

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8804-1EA - Each68788-88046dce041f-e879-4477-98f8-9ed56fbe1de612025-03-04
68788-8804-3EA - Each68788-8804ac0231d5-5592-48f2-b254-ce5e5b15020d12025-03-04
68788-8804-7EA - Each68788-8804129a64d0-8fa5-4fe2-bd1c-7297492e6f8f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8804SILDENAFIL CITRATE TABLET [PREFERRED PHARMACEUTICALS INC.]1Current NDC, 3 package rows20250122_5846bff2-6a93-46a7-a547-04459c590814.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN5846bff2-6a93-46a7-a547-04459c5908141
314229sildenafil 100 MG Oral TabletSCD5846bff2-6a93-46a7-a547-04459c5908141
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5846bff2-6a93-46a7-a547-04459c5908141

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68788-8804-16878888040110 TABLET in 1 BOTTLE (68788-8804-1) 10 tablet2025-01-20NoNoHistorical
68788-8804-36878888040330 TABLET in 1 BOTTLE (68788-8804-3) 30 tablet2025-01-20NoNoHistorical
68788-8804-7687888804077 TABLET in 1 BOTTLE (68788-8804-7) 7 tablet2025-01-20NoNoHistorical