FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
68071-3862
11-digit product format
680713862
Labeler code
68071
Product ID
68071-3862_521e7b08-8bdb-c4be-e063-6394a90a9124
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
NuCare Pharmaceuticals, Inc.
Application
ANDA091448
Marketing category
ANDA
Marketing start
2018-06-11
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-3862-1SILDENAFIL CITRATE10 in 1 BOTTLETABLET, FILM COATED104
68071-3862-5SILDENAFIL CITRATE15 in 1 BOTTLETABLET, FILM COATED154
68071-3862-6SILDENAFIL CITRATE60 in 1 BOTTLETABLET, FILM COATED604
68071-3862-9SILDENAFIL CITRATE90 in 1 BOTTLETABLET, FILM COATED904

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN36da8e3a-d17c-e42f-e063-6394a90a1ece4
314229sildenafil 100 MG Oral TabletSCD36da8e3a-d17c-e42f-e063-6394a90a1ece4
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY36da8e3a-d17c-e42f-e063-6394a90a1ece4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
68071-3862-16807138620110 TABLET, FILM COATED in 1 BOTTLE (68071-3862-1) 2026-05-18NoNoCurrent
68071-3862-56807138620515 TABLET, FILM COATED in 1 BOTTLE (68071-3862-5) 2025-06-11NoNoCurrent
68071-3862-66807138620660 TABLET, FILM COATED in 1 BOTTLE (68071-3862-6) 2025-06-11NoNoCurrent
68071-3862-96807138620990 TABLET, FILM COATED in 1 BOTTLE (68071-3862-9) 2025-06-05NoNoCurrent