FDA.reportPublic FDA data

Sildenafil

Product NDC
60219-1753
11-digit product format
602191753
Labeler code
60219
Product ID
60219-1753_8148bd41-7822-4d86-b60e-d6b01060d3a8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA202023
Marketing category
ANDA
Marketing start
2018-06-28
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
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
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1753-1Sildenafil100 in 1 BOTTLETABLET, FILM COATED10012
60219-1753-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED3012
60219-1753-7Sildenafil1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1753-3EA - Each60219-17537a949024-1edd-451b-85cf-2f18ae1c672c12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1753SILDENAFIL TABLET, FILM COATED [AMNEAL PHARMACEUTICALS NY LLC]12Current NDC, Legacy NDC, 3 package rows20231128_a1c3a2a2-8cf5-41c3-9c86-54290570d916.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314228sildenafil citrate 25 MG Oral TabletPSNa1c3a2a2-8cf5-41c3-9c86-54290570d91612
312950sildenafil citrate 50 MG Oral TabletPSNa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314229sildenafil 100 MG Oral TabletSCDa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314228sildenafil 25 MG Oral TabletSCDa1c3a2a2-8cf5-41c3-9c86-54290570d91612
312950sildenafil 50 MG Oral TabletSCDa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYa1c3a2a2-8cf5-41c3-9c86-54290570d91612
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYa1c3a2a2-8cf5-41c3-9c86-54290570d91612
314229sildenafil citrate 100 MG Oral TabletPSN96ae6733-cef9-46cf-bf4e-5368201943bd7
314229sildenafil 100 MG Oral TabletSCD96ae6733-cef9-46cf-bf4e-5368201943bd7
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY96ae6733-cef9-46cf-bf4e-5368201943bd7
314229sildenafil citrate 100 MG Oral TabletPSNf98d51a5-e3c8-2b6c-e053-6294a90ac1462
314229sildenafil 100 MG Oral TabletSCDf98d51a5-e3c8-2b6c-e053-6294a90ac1462
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf98d51a5-e3c8-2b6c-e053-6294a90ac1462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60219-1753-160219175301100 TABLET, FILM COATED in 1 BOTTLE (60219-1753-1) 2018-06-280000-00-00NoNoCurrent
60219-1753-36021917530330 TABLET, FILM COATED in 1 BOTTLE (60219-1753-3) 2018-06-280000-00-00NoNoCurrent
60219-1753-7602191753071000 TABLET, FILM COATED in 1 BOTTLE (60219-1753-7) 2018-06-28NoNoCurrent