FDA.reportPublic FDA data

SILDENAFIL

Product NDC
69097-953
11-digit product format
690970953
Labeler code
69097
Product ID
69097-953_31499b53-d7e9-49e4-8eaa-c527c7403f9c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET
Route
ORAL
Labeler
CIPLA USA INC.,
Application
ANDA207178
Marketing category
ANDA
Marketing start
2020-07-10
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69097-953-022023-05-02C16284748780-1d6a99b39-e11c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. Sildenafil tablets, for oral use Initial U.S. Approval: 1998
69097-953-072023-05-02C16284748780-1d6a99b39-e11c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. Sildenafil tablets, for oral use Initial U.S. Approval: 1998
69097-953-022022-01-28C16284748780-1d6a99b39-e11c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. Sildenafil tablets, for oral use Initial U.S. Approval: 1998
69097-953-072022-01-28C16284748780-1d6a99b39-e11c-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use SILDENAFIL TABLETS safely and effectively. See full prescribing information for SILDENAFIL TABLETS. Sildenafil tablets, for oral use Initial U.S. Approval: 1998

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69097-953-02SILDENAFIL30 in 1 BOTTLETABLET303
69097-953-07SILDENAFIL100 in 1 BOTTLETABLET1003

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69097-953-02EA - Each69097-95351b2b3a5-e60a-436d-91b8-2ca8abaa0d1012020-08-06
69097-953-07EA - Each69097-953f162c98d-7096-4fa9-8266-d852cee52cbd12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69097-953SILDENAFIL TABLET [CIPLA USA INC.,]3Current NDC, Legacy NDC, 2 package rows20230504_15372a7c-2935-48dc-a55a-8966719b50be.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil citrate 25 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil citrate 50 MG Oral TabletPSN15372a7c-2935-48dc-a55a-8966719b50be3
314229sildenafil 100 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil 25 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil 50 MG Oral TabletSCD15372a7c-2935-48dc-a55a-8966719b50be3
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY15372a7c-2935-48dc-a55a-8966719b50be3
314229sildenafil citrate 100 MG Oral TabletPSN7086e222-0f2b-4c02-84c0-4f8635c909932
314229sildenafil 100 MG Oral TabletSCD7086e222-0f2b-4c02-84c0-4f8635c909932
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY7086e222-0f2b-4c02-84c0-4f8635c909932

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69097-953-026909709530230 TABLET in 1 BOTTLE (69097-953-02) 30 tablet2020-07-100000-00-00NoNoCurrent
69097-953-0769097095307100 TABLET in 1 BOTTLE (69097-953-07) 100 tablet2020-07-100000-00-00NoNoCurrent