Sildenafil Citrate

Product NDC
68071-3670
11-digit product format
680713670
Labeler code
68071
Product ID
68071-3670_20ead088-c287-5465-e063-6394a90a7792
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil Citrate
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
25 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 CITRATE25 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314228

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3670-3Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-3670SILDENAFIL CITRATE TABLET, FILM COATED [NUCARE PHARMACEUTICALS, INC.]1Current NDC, 1 package rows20240901_20ead8ca-7cec-2d80-e063-6394a90af548.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314228sildenafil citrate 25 MG Oral TabletPSN20ead8ca-7cec-2d80-e063-6394a90af5481
314228sildenafil 25 MG Oral TabletSCD20ead8ca-7cec-2d80-e063-6394a90af5481
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY20ead8ca-7cec-2d80-e063-6394a90af5481

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3670-36807136700330 TABLET, FILM COATED in 1 BOTTLE (68071-3670-3) 2018-10-12NoNoHistorical