Sildenafil

Product NDC
60219-2651
11-digit product format
602192651
Labeler code
60219
Product ID
60219-2651_d13c8373-568f-485b-8b2e-94c2a2a2277e
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
2024-03-02
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
60219-2651-1Sildenafil112 mL in 1 BOTTLE, GLASSPOWDER, FOR SUSPENSION1121
60219-2651-1Sildenafil1 in 1 CARTONPOWDER, FOR SUSPENSION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60219-2651-1ML - Milliliter60219-265109151ea9-4313-4697-9e27-84d6223bc41f12025-03-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60219-2651SILDENAFIL POWDER, FOR SUSPENSION [AMNEAL PHARMACEUTICALS NY LLC]1Current NDC, 2 package rows20240303_845e6f49-2d5d-48b1-9ce5-26351536cbff.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1307427sildenafil 10 MG in 1 mL Oral SuspensionPSN845e6f49-2d5d-48b1-9ce5-26351536cbff1
1307427sildenafil 10 MG/ML Oral SuspensionSCD845e6f49-2d5d-48b1-9ce5-26351536cbff1
1307427sildenafil (as sildenafil citrate) 10 MG/ML Powder for Oral SuspensionSY845e6f49-2d5d-48b1-9ce5-26351536cbff1
1307427sildenafil 10 MG per 1 ML Oral SuspensionSY845e6f49-2d5d-48b1-9ce5-26351536cbff1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
60219-2651-1602192651011 BOTTLE, GLASS in 1 CARTON (60219-2651-1) / 112 mL in 1 BOTTLE, GLASS2024-03-02NoNoHistorical