FDA.reportPublic FDA data

Sildenafil

Product NDC
68788-7379
11-digit product format
687887379
Labeler code
68788
Product ID
68788-7379_2eb90f6c-a5de-472a-98eb-cdc027e74e2e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil citrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA202503
Marketing category
ANDA
Marketing start
2016-08-25
Marketing end
0000-00-00
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct68788-7379IInactivated by FDA2026-08-03
excluded packagepackage68788-737968788-7379-3IInactivated by FDA2026-08-03
excluded packagepackage68788-737968788-7379-4IInactivated by FDA2026-08-03
excluded packagepackage68788-737968788-7379-6IInactivated by FDA2026-08-03
excluded packagepackage68788-737968788-7379-9IInactivated by FDA2026-08-03

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A202503-001SILDENAFIL CITRATESILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
A202503-001AB

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A202503-001SILDENAFIL CITRATEEQ 20MG BASETABLET / ORALAB2012-11-06a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-01 22:54:322026-06A202503-001AB1a50c72e98297…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68788-7379-32020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese 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
68788-7379-42020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese 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
68788-7379-62020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese 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
68788-7379-92020-01-31C16284748780-19d75b9d0-a4ce-f424-e053-dadaa90a57ceThese 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
68788-7379-3Sildenafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED301
68788-7379-4Sildenafil4 in 1 BOTTLE, PLASTICTABLET, FILM COATED41
68788-7379-6Sildenafil60 in 1 BOTTLE, PLASTICTABLET, FILM COATED601
68788-7379-9Sildenafil90 in 1 BOTTLE, PLASTICTABLET, FILM COATED901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7379SILDENAFIL (SILDENAFIL CITRATE) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]1Legacy NDC, 4 package rows20160826_2eb90f6c-a5de-472a-98eb-cdc027e74e2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN2eb90f6c-a5de-472a-98eb-cdc027e74e2e1
577033sildenafil 20 MG Oral TabletSCD2eb90f6c-a5de-472a-98eb-cdc027e74e2e1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY2eb90f6c-a5de-472a-98eb-cdc027e74e2e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
68788-7379-36878873790330 in 1 BOTTLE, PLASTICHistorical
68788-7379-4687887379044 in 1 BOTTLE, PLASTICHistorical
68788-7379-66878873790660 in 1 BOTTLE, PLASTICHistorical
68788-7379-96878873790990 in 1 BOTTLE, PLASTICHistorical