FDA.reportPublic FDA data

Sildenafil

Product NDC
60219-1752
11-digit product format
602191752
Labeler code
60219
Product ID
60219-1752_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
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
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
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60219-1752-1Sildenafil100 in 1 BOTTLETABLET, FILM COATED10012
60219-1752-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED3012
60219-1752-7Sildenafil1000 in 1 BOTTLETABLET, FILM COATED100012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-1752-3EA - Each60219-1752993a8875-3915-4006-a9d4-028368f95da612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-1752SILDENAFIL 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
312950sildenafil citrate 50 MG Oral TabletPSNdfe4f616-b5de-458c-a97b-ab860e32320c9
312950sildenafil 50 MG Oral TabletSCDdfe4f616-b5de-458c-a97b-ab860e32320c9
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYdfe4f616-b5de-458c-a97b-ab860e32320c9
312950sildenafil citrate 50 MG Oral TabletPSN69361f7c-daef-4b17-9ee8-48e818df4dbb4
312950sildenafil 50 MG Oral TabletSCD69361f7c-daef-4b17-9ee8-48e818df4dbb4
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY69361f7c-daef-4b17-9ee8-48e818df4dbb4
312950sildenafil citrate 50 MG Oral TabletPSNef44442c-355e-7b8b-e053-2a95a90a21901
312950sildenafil citrate 50 MG Oral TabletPSN05ccb9cb-3cb6-5643-e063-6394a90ab3781
312950sildenafil 50 MG Oral TabletSCD05ccb9cb-3cb6-5643-e063-6394a90ab3781
312950sildenafil 50 MG Oral TabletSCDef44442c-355e-7b8b-e053-2a95a90a21901
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY05ccb9cb-3cb6-5643-e063-6394a90ab3781
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYef44442c-355e-7b8b-e053-2a95a90a21901

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
60219-1752-160219175201100 TABLET, FILM COATED in 1 BOTTLE (60219-1752-1) 2018-06-280000-00-00NoNoCurrent
60219-1752-36021917520330 TABLET, FILM COATED in 1 BOTTLE (60219-1752-3) 2018-06-280000-00-00NoNoCurrent
60219-1752-7602191752071000 TABLET, FILM COATED in 1 BOTTLE (60219-1752-7) 2018-06-28NoNoCurrent