FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
68071-3410
11-digit product format
680713410
Labeler code
68071
Product ID
68071-3410_4d77851a-5e05-33af-e063-6294a90a2c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA206401
Marketing category
ANDA
Marketing start
2018-10-12
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil Citrate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
68071-3410-32025-02-04C16284748780-12cef2736-7478-d83d-e063-dadaa90ab31fThese 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
68071-3410-32025-01-30C16284748780-12cef2736-7478-d83d-e063-dadaa90ab31fThese 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
68071-3410-3Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3410SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]3Current NDC, 1 package rows20250207_fbe75c2c-0aff-9ade-e053-6394a90a1ea4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNfbe75c2c-0aff-9ade-e053-6394a90a1ea44
314229sildenafil 100 MG Oral TabletSCDfbe75c2c-0aff-9ade-e053-6394a90a1ea44
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYfbe75c2c-0aff-9ade-e053-6394a90a1ea44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3410-36807134100330 TABLET, FILM COATED in 1 BOTTLE (68071-3410-3) 2023-05-18NoNoCurrent