FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
72789-405
11-digit product format
727890405
Labeler code
72789
Product ID
72789-405_31f6c2bb-9a5b-e2f0-e063-6294a90aace5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2020-09-04
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

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
72789-405-15SILDENAFIL CITRATE15 in 1 BOTTLE, PLASTICTABLET1512
72789-405-30SILDENAFIL CITRATE30 in 1 BOTTLE, PLASTICTABLET3012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72789-405-15EA - Each72789-4054d76409e-b8ca-4755-b573-7751bdb72f2c12024-07-12
72789-405-30EA - Each72789-4050540a430-e818-4ae3-8d37-f9fbc1d6b67c12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72789-405SILDENAFIL CITRATE TABLET [PD-RX PHARMACEUTICALS, INC.]12Current NDC, 2 package rows20250406_dc4430cc-8238-4d6d-99ff-bbb9d0b51bd1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNdc4430cc-8238-4d6d-99ff-bbb9d0b51bd112
312950sildenafil 50 MG Oral TabletSCDdc4430cc-8238-4d6d-99ff-bbb9d0b51bd112
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdc4430cc-8238-4d6d-99ff-bbb9d0b51bd112

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72789-405-157278904051515 TABLET in 1 BOTTLE, PLASTIC (72789-405-15) 15 tablet2024-06-07NoNoCurrent
72789-405-307278904053030 TABLET in 1 BOTTLE, PLASTIC (72789-405-30) 30 tablet2024-06-07NoNoCurrent