FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-2602
11-digit product format
680712602
Labeler code
68071
Product ID
68071-2602_3ab073e6-dfb5-0795-e063-6294a90ab146
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2018-05-04
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68071-2602-32025-07-24C16284748780-1f386c64a-15eb-0266-e053-dadaa90a7c1aThese 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
68071-2602-32025-01-30C16284748780-1f386c64a-15eb-0266-e053-dadaa90a7c1aThese 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
68071-2602-32023-07-14C16284748780-1f386c64a-15eb-0266-e053-dadaa90a7c1aThese 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
68071-2602-32023-01-30C16284748780-1f386c64a-15eb-0266-e053-dadaa90a7c1aThese 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
68071-2602-1Sildenafil10 in 1 BOTTLETABLET103
68071-2602-3Sildenafil30 in 1 BOTTLETABLET303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2602SILDENAFIL TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 2 package rows20230715_d35f8d6b-e642-78bb-e053-2995a90abb2e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG Oral TabletSCDd35f8d6b-e642-78bb-e053-2995a90abb2e3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd35f8d6b-e642-78bb-e053-2995a90abb2e3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2602-16807126020110 TABLET in 1 BOTTLE (68071-2602-1) 10 tablet2025-07-24NoNoCurrent
68071-2602-36807126020330 TABLET in 1 BOTTLE (68071-2602-3) 30 tablet2021-12-170000-00-00NoNoCurrent