FDA.reportPublic FDA data

sildenafil CITRATE

Product NDC
59651-420
11-digit product format
596510420
Labeler code
59651
Product ID
59651-420_39509319-16be-4fc4-a60a-48ea8e9333c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil CITRATE
Dosage form
POWDER, FOR SUSPENSION
Route
ORAL
Labeler
Aurobindo Pharma Limited
Application
ANDA214773
Marketing category
ANDA
Marketing start
2022-12-23
Substance
SILDENAFIL CITRATE
Active strength
10 mg/mL
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 CITRATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59651-420-11sildenafil CITRATE112 mL in 1 BOTTLEPOWDER, FOR SUSPENSION1124
59651-420-11sildenafil CITRATE1 in 1 CARTONPOWDER, FOR SUSPENSION14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59651-420-11ML - Milliliter59651-4203c9479ca-eee8-4709-96eb-e2df495fb41912024-01-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59651-420SILDENAFIL CITRATE POWDER, FOR SUSPENSION [AUROBINDO PHARMA LIMITED]3Current NDC, Legacy NDC, 2 package rows20240126_b60b4fdc-9b78-45e6-8438-8a30f83ed976.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSNb60b4fdc-9b78-45e6-8438-8a30f83ed9764
1307427sildenafil 10 MG/ML Oral SuspensionSCDb60b4fdc-9b78-45e6-8438-8a30f83ed9764
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSYb60b4fdc-9b78-45e6-8438-8a30f83ed9764
1307427sildenafil 10 MG per 1 ML Oral SuspensionSYb60b4fdc-9b78-45e6-8438-8a30f83ed9764

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
59651-420-11596510420111 BOTTLE in 1 CARTON (59651-420-11) / 112 mL in 1 BOTTLE1 bottle2022-12-230000-00-00NoNoCurrent