Sildenafil Citrate

Product NDC
68071-3646
11-digit product format
680713646
Labeler code
68071
Product ID
68071-3646_2a2fe9ea-d9e4-9057-e063-6394a90af294
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
2024-07-16
Substance
SILDENAFIL CITRATE
Active strength
50 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 Citrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fabccea2-36c8-9268-ee44-ec231455538fProduct name920241217
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3646-1Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED102

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3646SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]2Current NDC, 1 package rows20241228_1d614710-708e-f11c-e063-6394a90a05a5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN1d614710-708e-f11c-e063-6394a90a05a52
312950sildenafil 50 MG Oral TabletSCD1d614710-708e-f11c-e063-6394a90a05a52
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY1d614710-708e-f11c-e063-6394a90a05a52

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3646-16807136460110 TABLET, FILM COATED in 1 BOTTLE (68071-3646-1) 2024-07-16NoNoCurrent