Sildenafil

Product NDC
69238-1574
11-digit product format
692381574
Labeler code
69238
Product ID
69238-1574_87224b5f-b3ee-40e4-8ac1-45356a1b86eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Amneal Pharmaceuticals NY LLC
Application
ANDA211092
Marketing category
ANDA
Marketing start
2019-12-06
Substance
SILDENAFIL
Active strength
10 mg/mL
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
SILDENAFIL10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3M7OB98Y7H
Rxcui1307427

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
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69238-1574-1Sildenafil112 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION11218
69238-1574-1Sildenafil1 in 1 CARTONPOWDER, FOR SUSPENSION118

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69238-1574SILDENAFIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]18Current NDC, Legacy NDC, 2 package rows20240118_9de84092-ebe6-436c-a925-88a6e3861eba.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN9de84092-ebe6-436c-a925-88a6e3861eba18
1307427sildenafil 10 MG/ML Oral SuspensionSCD9de84092-ebe6-436c-a925-88a6e3861eba18
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY9de84092-ebe6-436c-a925-88a6e3861eba18
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY9de84092-ebe6-436c-a925-88a6e3861eba18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69238-1574-1692381574011 BOTTLE, GLASS in 1 CARTON (69238-1574-1) / 112 mL in 1 BOTTLE, GLASS2019-12-060000-00-00NoNoCurrent