FDA.reportPublic FDA data

Sildenafil

Product NDC
68071-3954
11-digit product format
680713954
Labeler code
68071
Product ID
68071-3954_4f97a742-fd7b-75ff-e063-6294a90adf67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3954-9Sildenafil90 in 1 BOTTLETABLET, FILM COATED901

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG Oral TabletSCD48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY48c56418-0e45-083f-e063-6294a90a57b31

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3954-96807139540990 TABLET, FILM COATED in 1 BOTTLE (68071-3954-9) 2026-01-19NoNoHistorical