Sildenafil Citrate

Product NDC
68071-3592
11-digit product format
680713592
Labeler code
68071
Product ID
68071-3592_308be64f-e32f-b592-e063-6394a90a451b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
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
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 CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314228

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3592-1Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED102
68071-3592-9Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3592SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 2 package rows20250321_155c7549-b7d6-0c06-e063-6294a90ac65c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSN155c7549-b7d6-0c06-e063-6294a90ac65c2
314228sildenafil 25 MG Oral TabletSCD155c7549-b7d6-0c06-e063-6294a90ac65c2
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY155c7549-b7d6-0c06-e063-6294a90ac65c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3592-16807135920110 TABLET, FILM COATED in 1 BOTTLE (68071-3592-1) 2025-03-17NoNoCurrent
68071-3592-96807135920990 TABLET, FILM COATED in 1 BOTTLE (68071-3592-9) 2024-04-05NoNoCurrent