Sildenafil

Product NDC
68071-3745
11-digit product format
680713745
Labeler code
68071
Product ID
68071-3745_45c93036-57c7-efb3-e063-6294a90a1965
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
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
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
68071-3745-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED103
68071-3745-5Sildenafil45 in 1 BOTTLETABLET, FILM COATED453
68071-3745-6Sildenafil60 in 1 BOTTLETABLET, FILM COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3745SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 3 package rows20241215_2916e6c4-bc68-c4d6-e063-6394a90aba79.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN2916e6c4-bc68-c4d6-e063-6394a90aba793
312950sildenafil 50 MG Oral TabletSCD2916e6c4-bc68-c4d6-e063-6394a90aba793
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY2916e6c4-bc68-c4d6-e063-6394a90aba793

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3745-16807137450110 TABLET, FILM COATED in 1 BOTTLE (68071-3745-1) 2025-12-12NoNoCurrent
68071-3745-56807137450545 TABLET, FILM COATED in 1 BOTTLE (68071-3745-5) 2025-10-09NoNoCurrent
68071-3745-66807137450660 TABLET, FILM COATED in 1 BOTTLE (68071-3745-6) 2024-12-12NoNoCurrent