FDA.reportPublic FDA data

Sildenafil

Product NDC
65862-689
11-digit product format
658620689
Labeler code
65862
Product ID
65862-689_98bf3100-9a4e-45d5-9f6b-1fa1a06b26b8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA203962
Marketing category
ANDA
Marketing start
2018-06-11
Substance
SILDENAFIL CITRATE
Active strength
25 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 CITRATE25 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
65862-689-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1006
65862-689-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED5006
65862-689-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED306
65862-689-99Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65862-689-30EA - Each65862-689a6bf3ac1-ed16-409c-8443-8b30e9e2a49012018-07-03
65862-689-99EA - Each65862-689bde25bf0-994f-4ca7-8309-42ea56c498bd12024-02-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65862-689SILDENAFIL TABLET, FILM COATED [AUROBINDO PHARMA LIMITED]6Current NDC, Legacy NDC, 4 package rows20240618_363c1e77-e482-47b2-aa1e-851abd770aeb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil citrate 25 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil citrate 50 MG Oral TabletPSN363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG Oral TabletSCD363c1e77-e482-47b2-aa1e-851abd770aeb6
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY363c1e77-e482-47b2-aa1e-851abd770aeb6
314228sildenafil citrate 25 MG Oral TabletPSNa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83
314228sildenafil 25 MG Oral TabletSCDa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYa10b7ec1-bb59-4906-b32d-fbd2a17ed7a83

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
65862-689-0165862068901100 TABLET, FILM COATED in 1 BOTTLE (65862-689-01) 2018-06-110000-00-00NoNoCurrent
65862-689-0565862068905500 TABLET, FILM COATED in 1 BOTTLE (65862-689-05) 2023-07-10NoNoHistorical
65862-689-306586206893030 TABLET, FILM COATED in 1 BOTTLE (65862-689-30) 2018-06-110000-00-00NoNoCurrent
65862-689-99658620689991000 TABLET, FILM COATED in 1 BOTTLE (65862-689-99) 2018-06-110000-00-00NoNoCurrent