FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
27241-069
11-digit product format
272410069
Labeler code
27241
Product ID
27241-069_693e54c2-18ce-4ef0-8b65-894bff61dd9e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Ajanta Pharma USA Inc.
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
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
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 CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950, 314228, 314229

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
27241-069-03Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED3012
27241-069-05Sildenafil Citrate500 in 1 BOTTLETABLET, FILM COATED50012
27241-069-10Sildenafil Citrate100 in 1 BOTTLETABLET, FILM COATED10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-069-03EA - Each27241-069977f3a7e-d072-4eb5-a459-ffe1049bbd7b12018-12-13
27241-069-05EA - Each27241-069c11ec5d9-b211-4510-ba9f-b02007c0902d12025-05-14
27241-069-10EA - Each27241-0699c03312c-8332-46db-ace8-61945091409d12018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-069SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [AJANTA PHARMA USA INC.]11Current NDC, Legacy NDC, 3 package rows20241204_2ccc6fa6-f8ae-4191-806f-a887244e516a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN2ccc6fa6-f8ae-4191-806f-a887244e516a12
314228sildenafil citrate 25 MG Oral TabletPSN2ccc6fa6-f8ae-4191-806f-a887244e516a12
312950sildenafil citrate 50 MG Oral TabletPSN2ccc6fa6-f8ae-4191-806f-a887244e516a12
314229sildenafil 100 MG Oral TabletSCD2ccc6fa6-f8ae-4191-806f-a887244e516a12
314228sildenafil 25 MG Oral TabletSCD2ccc6fa6-f8ae-4191-806f-a887244e516a12
312950sildenafil 50 MG Oral TabletSCD2ccc6fa6-f8ae-4191-806f-a887244e516a12
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY2ccc6fa6-f8ae-4191-806f-a887244e516a12
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY2ccc6fa6-f8ae-4191-806f-a887244e516a12
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY2ccc6fa6-f8ae-4191-806f-a887244e516a12
314229sildenafil citrate 100 MG Oral TabletPSN824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5
314229sildenafil 100 MG Oral TabletSCD824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY824dcd79-bc82-4b3a-8028-3c1bca1a7a0a5
314229sildenafil citrate 100 MG Oral TabletPSN0bb3eb8d-05cd-b4cd-e063-6294a90a94bb4
314229sildenafil citrate 100 MG Oral TabletPSN878b4c44-cddc-42cb-b9b5-911451ad15304
314229sildenafil citrate 100 MG Oral TabletPSNfbe75c2c-0aff-9ade-e053-6394a90a1ea44
314229sildenafil 100 MG Oral TabletSCDfbe75c2c-0aff-9ade-e053-6394a90a1ea44
314229sildenafil 100 MG Oral TabletSCD878b4c44-cddc-42cb-b9b5-911451ad15304
314229sildenafil 100 MG Oral TabletSCD0bb3eb8d-05cd-b4cd-e063-6294a90a94bb4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0bb3eb8d-05cd-b4cd-e063-6294a90a94bb4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYfbe75c2c-0aff-9ade-e053-6394a90a1ea44
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY878b4c44-cddc-42cb-b9b5-911451ad15304
314229sildenafil citrate 100 MG Oral TabletPSN1ceb575b-2687-0456-e063-6394a90aa88a1
314229sildenafil citrate 100 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil citrate 100 MG Oral TabletPSNb9b1d6ee-da42-4ef2-ab93-cd36d7f341501
314228sildenafil citrate 25 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil citrate 50 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG Oral TabletSCD1ceb575b-2687-0456-e063-6394a90aa88a1
314229sildenafil 100 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG Oral TabletSCDb9b1d6ee-da42-4ef2-ab93-cd36d7f341501
314228sildenafil 25 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil 50 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYb9b1d6ee-da42-4ef2-ab93-cd36d7f341501
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY1ceb575b-2687-0456-e063-6394a90aa88a1
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY0500a861-359f-4e12-beb5-0cac8cd6ae1c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
27241-069-032724100690330 TABLET, FILM COATED in 1 BOTTLE (27241-069-03) 2018-10-120000-00-00NoNoCurrent
27241-069-0527241006905500 TABLET, FILM COATED in 1 BOTTLE (27241-069-05) 2024-07-29NoNoCurrent
27241-069-1027241006910100 TABLET, FILM COATED in 1 BOTTLE (27241-069-10) 2018-10-120000-00-00NoNoCurrent