FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
27241-068
11-digit product format
272410068
Labeler code
27241
Product ID
27241-068_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
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 Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 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
27241-068-03Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED3012
27241-068-05Sildenafil Citrate500 in 1 BOTTLETABLET, FILM COATED50012
27241-068-10Sildenafil Citrate100 in 1 BOTTLETABLET, FILM COATED10012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
27241-068-03EA - Each27241-068bcf51b77-0372-4e92-8a8c-5128f442bb1112018-12-13
27241-068-05EA - Each27241-068bf0c277f-3ee4-4845-965f-877b735ba06a12025-05-14
27241-068-10EA - Each27241-0684211f625-8573-40e3-96b9-b2e3aa7d771412018-12-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
27241-068SILDENAFIL 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
312950sildenafil citrate 50 MG Oral TabletPSN1d614710-708e-f11c-e063-6394a90a05a52
312950sildenafil 50 MG Oral TabletSCD1d614710-708e-f11c-e063-6394a90a05a52
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY1d614710-708e-f11c-e063-6394a90a05a52
314229sildenafil citrate 100 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314228sildenafil citrate 25 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil citrate 50 MG Oral TabletPSN1b1ab00d-de9c-4614-e063-6394a90afcde1
312950sildenafil citrate 50 MG Oral TabletPSN0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314228sildenafil 25 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil 50 MG Oral TabletSCD1b1ab00d-de9c-4614-e063-6394a90afcde1
312950sildenafil 50 MG Oral TabletSCD0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY0500a861-359f-4e12-beb5-0cac8cd6ae1c1
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY0500a861-359f-4e12-beb5-0cac8cd6ae1c1
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY1b1ab00d-de9c-4614-e063-6394a90afcde1
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
27241-068-032724100680330 TABLET, FILM COATED in 1 BOTTLE (27241-068-03) 2018-10-120000-00-00NoNoCurrent
27241-068-0527241006805500 TABLET, FILM COATED in 1 BOTTLE (27241-068-05) 2024-07-29NoNoCurrent
27241-068-1027241006810100 TABLET, FILM COATED in 1 BOTTLE (27241-068-10) 2018-10-120000-00-00NoNoCurrent