FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
52817-295
11-digit product format
528170295
Labeler code
52817
Product ID
52817-295_a8abd38f-2334-34e3-e053-2a95a90acb7d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
TruPharma LLC
Application
ANDA204883
Marketing category
ANDA
Marketing start
2016-08-01
Substance
SILDENAFIL CITRATE
Active strength
20 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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
52817-295-00Sildenafil Citrate1000 in 1 BOTTLETABLET, FILM COATED10006
52817-295-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
52817-295-00EA - Each52817-295a47308e2-77b4-4975-9304-8ce20f48558d12019-06-19
52817-295-90EA - Each52817-2958d78ef7c-81a9-46c2-951e-a6782e9dd1b412019-02-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52817-295SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [TRUPHARMA LLC]6Current NDC, Legacy NDC, 2 package rows20200623_c8864c64-22ad-402b-a1e8-cfb53fa02e80.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil 20 MG Oral TabletSCDc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc8864c64-22ad-402b-a1e8-cfb53fa02e806
577033sildenafil citrate 20 MG Oral TabletPSN479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG Oral TabletSCD479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY479fb45a-ae9d-40a5-bcf4-34ec55ecdacd3
577033sildenafil citrate 20 MG Oral TabletPSNd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil citrate 20 MG Oral TabletPSNf4c26992-c9bb-e20f-e053-2a95a90afb652
577033sildenafil citrate 20 MG Oral TabletPSNf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil citrate 20 MG Oral TabletPSN9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG Oral TabletSCDd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG Oral TabletSCDf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG Oral TabletSCD9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG Oral TabletSCDf4c26992-c9bb-e20f-e053-2a95a90afb652
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd9ddfd2a-1961-90f9-e053-2a95a90a7f9b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf0fc8f9c-7173-4d51-a39a-49437e7e73ee2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY9ebc1a11-3f4b-4eb3-89f5-f430a330887d2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf4c26992-c9bb-e20f-e053-2a95a90afb652

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
52817-295-00528170295001000 TABLET, FILM COATED in 1 BOTTLE (52817-295-00) 2016-08-010000-00-00NoNoCurrent
52817-295-905281702959090 TABLET, FILM COATED in 1 BOTTLE (52817-295-90) 2016-08-010000-00-00NoNoCurrent