FDA.reportPublic FDA data

Sildenafil

Product NDC
33342-042
11-digit product format
333420042
Labeler code
33342
Product ID
33342-042_e89d523d-8d42-4bbf-be3d-2b15e7c15f4f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA202255
Marketing category
ANDA
Marketing start
2023-04-19
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
33342-042-07Sildenafil30 in 1 BOTTLETABLET, FILM COATED305
33342-042-11Sildenafil100 in 1 BOTTLETABLET, FILM COATED1005
33342-042-44Sildenafil1000 in 1 BOTTLETABLET, FILM COATED10005
33342-042-98Sildenafil60 in 1 BLISTER PACKTABLET, FILM COATED605
33342-042-98Sildenafil1 in 1 CARTONTABLET, FILM COATED15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-042SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]1Current NDC, 5 package rows20230505_c2b25818-99a3-474b-a04c-929df1110834.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNc2b25818-99a3-474b-a04c-929df11108345
314228sildenafil citrate 25 MG Oral TabletPSNc2b25818-99a3-474b-a04c-929df11108345
312950sildenafil citrate 50 MG Oral TabletPSNc2b25818-99a3-474b-a04c-929df11108345
314229sildenafil 100 MG Oral TabletSCDc2b25818-99a3-474b-a04c-929df11108345
314228sildenafil 25 MG Oral TabletSCDc2b25818-99a3-474b-a04c-929df11108345
312950sildenafil 50 MG Oral TabletSCDc2b25818-99a3-474b-a04c-929df11108345
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYc2b25818-99a3-474b-a04c-929df11108345
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYc2b25818-99a3-474b-a04c-929df11108345
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYc2b25818-99a3-474b-a04c-929df11108345
312950sildenafil citrate 50 MG Oral TabletPSN4df47282-7950-9430-e063-6394a90af5791
312950sildenafil citrate 50 MG Oral TabletPSN9143e0ab-0fa1-4718-919c-ddfd1e9b83861
312950sildenafil 50 MG Oral TabletSCD4df47282-7950-9430-e063-6394a90af5791
312950sildenafil 50 MG Oral TabletSCD9143e0ab-0fa1-4718-919c-ddfd1e9b83861
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY4df47282-7950-9430-e063-6394a90af5791
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY9143e0ab-0fa1-4718-919c-ddfd1e9b83861

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
33342-042-073334200420730 TABLET, FILM COATED in 1 BOTTLE (33342-042-07) 2023-04-19NoNoCurrent
33342-042-1133342004211100 TABLET, FILM COATED in 1 BOTTLE (33342-042-11) 2023-04-19NoNoCurrent
33342-042-44333420042441000 TABLET, FILM COATED in 1 BOTTLE (33342-042-44) 2023-04-19NoNoCurrent
33342-042-98333420042981 BLISTER PACK in 1 CARTON (33342-042-98) / 60 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2023-04-19NoNoCurrent