FDA.reportPublic FDA data

Sildenafil

Product NDC
68788-7879
11-digit product format
687887879
Labeler code
68788
Product ID
68788-7879_be069c7b-77d7-4eee-b686-969fd72b8d84
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Preferred Pharmaceuticals, Inc.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2021-03-08
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
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
68788-7879-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED105
68788-7879-7Sildenafil7 in 1 BOTTLETABLET, FILM COATED75

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-7879-1EA - Each68788-7879c0241b96-5986-4bf3-b9a9-2345606f42b912021-04-08
68788-7879-7EA - Each68788-78796a2c97bd-4cf0-4238-8f87-9c7d5e97277812021-04-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-7879SILDENAFIL TABLET, FILM COATED [PREFERRED PHARMACEUTICALS, INC.]4Current NDC, Legacy NDC, 2 package rows20240810_174ef537-e3e6-42bd-a478-47b930ddc761.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN174ef537-e3e6-42bd-a478-47b930ddc7615
314229sildenafil 100 MG Oral TabletSCD174ef537-e3e6-42bd-a478-47b930ddc7615
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY174ef537-e3e6-42bd-a478-47b930ddc7615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68788-7879-16878878790110 TABLET, FILM COATED in 1 BOTTLE (68788-7879-1) 2021-03-080000-00-00NoNoCurrent
68788-7879-7687887879077 TABLET, FILM COATED in 1 BOTTLE (68788-7879-7) 2021-03-080000-00-00NoNoCurrent