Sildenafil

Product NDC
50090-7964
11-digit product format
500907964
Labeler code
50090
Product ID
50090-7964_62d37665-6ab6-488d-a165-e76ea6554baf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2027-12-31

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
50090-7964-0Sildenafil10 in 1 BOTTLETABLET, FILM COATED101
50090-7964-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED301

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG Oral TabletSCD18bd4315-2446-415b-a6a3-991ba00357681
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY18bd4315-2446-415b-a6a3-991ba00357681

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50090-7964-05009079640010 TABLET, FILM COATED in 1 BOTTLE (50090-7964-0) 2026-05-13NoNoCurrent
50090-7964-15009079640130 TABLET, FILM COATED in 1 BOTTLE (50090-7964-1) 2026-05-13NoNoCurrent