FDA.reportPublic FDA data

Sildenafil

Product NDC
27241-124
11-digit product format
272410124
Labeler code
27241
Product ID
27241-124_f5da6ecc-eebe-409e-9251-869a73ef4d4e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2018-05-04
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
27241-124-03Sildenafil90 in 1 BOTTLETABLET9012
27241-124-05Sildenafil500 in 1 BOTTLETABLET50012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-124-03EA - Each27241-124222b908b-7487-4926-b58e-b007cbc9bc1f12018-11-06
27241-124-05EA - Each27241-124c0c938ab-f963-44ad-8067-b20fa36cbee812025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-124SILDENAFIL TABLET [AJANTA PHARMA USA INC.]10Current NDC, Legacy NDC, 2 package rows20250306_31c0f8ab-ed2e-4ead-a8c0-4055f6c43783.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG Oral TabletSCDfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYfe848310-57d8-4492-829c-3e2535754a55104
577033sildenafil citrate 20 MG Oral TabletPSN31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
577033sildenafil 20 MG Oral TabletSCD31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY31c0f8ab-ed2e-4ead-a8c0-4055f6c4378312
577033sildenafil citrate 20 MG Oral TabletPSNe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG Oral TabletSCDe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil citrate 20 MG Oral TabletPSNd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG Oral TabletSCDd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd1ee9139-13ac-7d5b-e053-2995a90a8e506
577033sildenafil citrate 20 MG Oral TabletPSNd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG Oral TabletSCDd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd887377e-90c5-44dc-8455-b23a6755b36f4
577033sildenafil citrate 20 MG Oral TabletPSNd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil citrate 20 MG Oral TabletPSNd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil citrate 20 MG Oral TabletPSNcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil 20 MG Oral TabletSCDd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil 20 MG Oral TabletSCDd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG Oral TabletSCDcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd462e818-af97-0b23-e053-2995a90ace223
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYcc3656ac-3a38-a650-e053-2a95a90a912a3
577033sildenafil citrate 20 MG Oral TabletPSN7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG Oral TabletSCD7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7dd302cd-b84d-4d7d-bd1e-2916febbaea52
577033sildenafil citrate 20 MG Oral TabletPSNefd56b83-79ce-42fa-a690-6bbe5e766d4e1
577033sildenafil 20 MG Oral TabletSCDefd56b83-79ce-42fa-a690-6bbe5e766d4e1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYefd56b83-79ce-42fa-a690-6bbe5e766d4e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
27241-124-032724101240390 TABLET in 1 BOTTLE (27241-124-03) 90 tablet2018-05-040000-00-00NoNoCurrent
27241-124-0527241012405500 TABLET in 1 BOTTLE (27241-124-05) 500 tablet2025-08-19NoNoHistorical