FDA.reportPublic FDA data

Sildenafil

Product NDC
70518-3433
11-digit product format
705183433
Labeler code
70518
Product ID
70518-3433_485bc9db-8666-9f5a-e063-6394a90a7921
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA210394
Marketing category
ANDA
Marketing start
2022-06-09
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
70518-3433-0Sildenafil30 in 1 BOXTABLET3010
70518-3433-1Sildenafil1 in 1 POUCHTABLET110
70518-3433-2Sildenafil360 in 1 BOXTABLET36010
70518-3433-3Sildenafil90 in 1 BOXTABLET9010
70518-3433-4Sildenafil180 in 1 BOXTABLET18010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-3433SILDENAFIL TABLET [REMEDYREPACK INC.]7Current NDC, Legacy NDC, 5 package rows20250112_e4f41e9e-d508-4f91-8677-8a19b07139de.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSNe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG Oral TabletSCDe4f41e9e-d508-4f91-8677-8a19b07139de10
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYe4f41e9e-d508-4f91-8677-8a19b07139de10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70518-3433-07051834330030 POUCH in 1 BOX (70518-3433-0) / 1 TABLET in 1 POUCH (70518-3433-1) 30 pouch2022-06-090000-00-00NoNoCurrent
70518-3433-1705183433011 in 1 POUCHHistorical
70518-3433-270518343302360 POUCH in 1 BOX (70518-3433-2) / 1 TABLET in 1 POUCH (70518-3433-1) 360 pouch2022-06-090000-00-00NoNoCurrent
70518-3433-37051834330390 in 1 BOXHistorical
70518-3433-470518343304180 POUCH in 1 BOX (70518-3433-4) / 1 TABLET in 1 POUCH (70518-3433-1) 180 pouch2024-01-10NoNoHistorical