FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-2985
11-digit product format
680712985
Labeler code
68071
Product ID
68071-2985_2dcdd45a-556b-0b9f-e063-6394a90a8a3f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA202023
Marketing category
ANDA
Marketing start
2018-06-28
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
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
68071-2985-32025-02-10C16284748780-12cef2736-a027-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
68071-2985-32025-01-30C16284748780-12cef2736-a027-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
68071-2985-3Sildenafil30 in 1 BOTTLETABLET, FILM COATED302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2985SILDENAFIL TABLET, FILM COATED [NUCARE PHARMACEUTICALS,INC.]2Current NDC, 1 package rows20250212_f98d51a5-e3c8-2b6c-e053-6294a90ac146.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf98d51a5-e3c8-2b6c-e053-6294a90ac1462
314229sildenafil 100 MG Oral TabletSCDf98d51a5-e3c8-2b6c-e053-6294a90ac1462
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf98d51a5-e3c8-2b6c-e053-6294a90ac1462

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-2985-36807129850330 TABLET, FILM COATED in 1 BOTTLE (68071-2985-3) 2023-04-17NoNoCurrent