Sildenafil

Product NDC
70518-1844
11-digit product format
705181844
Labeler code
70518
Product ID
70518-1844_4977420c-2205-90c0-e063-6294a90a898d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
REMEDYREPACK INC.
Application
ANDA202659
Marketing category
ANDA
Marketing start
2019-02-04
Substance
SILDENAFIL CITRATE
Active strength
50 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 CITRATE50 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui312950

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
70518-1844-0Sildenafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010
70518-1844-1Sildenafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1844SILDENAFIL TABLET, FILM COATED [REMEDYREPACK INC.]8Current NDC, Legacy NDC, 2 package rows20250302_99bc66a4-05d1-4372-a25a-1153d7af580e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN99bc66a4-05d1-4372-a25a-1153d7af580e10
312950sildenafil 50 MG Oral TabletSCD99bc66a4-05d1-4372-a25a-1153d7af580e10
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY99bc66a4-05d1-4372-a25a-1153d7af580e10

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70518-1844-07051818440030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1844-0) 2019-02-040000-00-00NoNoCurrent
70518-1844-17051818440130 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (70518-1844-1) 2022-12-120000-00-00NoNoCurrent