Sildenafil

Product NDC
68071-2213
11-digit product format
680712213
Labeler code
68071
Product ID
68071-2213_2abf56a9-a510-5e24-e063-6394a90aa2e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203623
Marketing category
ANDA
Marketing start
2014-11-26
Substance
SILDENAFIL CITRATE
Active strength
20 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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
68071-2213-9Sildenafil90 in 1 BOTTLETABLET, FILM COATED905

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2213SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]5Current NDC, Legacy NDC, 1 package rows20250104_a9f0e832-e85c-975f-e053-2995a90afa22.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNa9f0e832-e85c-975f-e053-2995a90afa225
577033sildenafil 20 MG Oral TabletSCDa9f0e832-e85c-975f-e053-2995a90afa225
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa9f0e832-e85c-975f-e053-2995a90afa225

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68071-2213-96807122130990 TABLET, FILM COATED in 1 BOTTLE (68071-2213-9) 2020-07-080000-00-00NoNoCurrent