FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
68788-8301
11-digit product format
687888301
Labeler code
68788
Product ID
68788-8301_51b0c63b-9583-4996-9e18-081a4d94eee3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA206401
Marketing category
ANDA
Marketing start
2022-11-30
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
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 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
68788-8301-1Sildenafil Citrate10 in 1 BOTTLETABLET, FILM COATED104
68788-8301-3Sildenafil Citrate30 in 1 BOTTLETABLET, FILM COATED304
68788-8301-7Sildenafil Citrate7 in 1 BOTTLETABLET, FILM COATED74

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8301-1EA - Each68788-8301f3306230-89ad-4b4d-a701-6e73c0ff88f912023-01-09
68788-8301-3EA - Each68788-830169d3f75a-a4e2-4bd2-b0bb-fa257817ef8012023-01-09
68788-8301-7EA - Each68788-83015717931c-fd46-4daf-946f-b3045e6407e812023-01-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8301SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PREFERRED PHARMACEUTICALS INC.]3Current NDC, Legacy NDC, 3 package rows20240810_878b4c44-cddc-42cb-b9b5-911451ad1530.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN878b4c44-cddc-42cb-b9b5-911451ad15304
314229sildenafil 100 MG Oral TabletSCD878b4c44-cddc-42cb-b9b5-911451ad15304
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY878b4c44-cddc-42cb-b9b5-911451ad15304

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-8301-16878883010110 TABLET, FILM COATED in 1 BOTTLE (68788-8301-1) 2022-11-300000-00-00NoNoCurrent
68788-8301-36878883010330 TABLET, FILM COATED in 1 BOTTLE (68788-8301-3) 2022-11-300000-00-00NoNoCurrent
68788-8301-7687888301077 TABLET, FILM COATED in 1 BOTTLE (68788-8301-7) 2022-11-300000-00-00NoNoCurrent