FDA.reportPublic FDA data

Sildenafil

Product NDC
43063-982
11-digit product format
430630982
Labeler code
43063
Product ID
43063-982_303a8d17-68c8-fd01-e063-6394a90a4fd8
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA203963
Marketing category
ANDA
Marketing start
2015-11-18
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
2026-12-31
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

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
43063-982-10Sildenafil10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1018
43063-982-30Sildenafil30 in 1 BOTTLE, PLASTICTABLET, FILM COATED3018

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-982-10EA - Each43063-98204190166-6259-4801-81da-fd9050b0733a12019-09-05
43063-982-30EA - Each43063-982cd0f9d06-33d3-48cc-b003-53dcda121d2312019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-982SILDENAFIL TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20250316_4ca5555d-fd45-467b-8b1d-4fbe1404f1f3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN4ca5555d-fd45-467b-8b1d-4fbe1404f1f318
577033sildenafil 20 MG Oral TabletSCD4ca5555d-fd45-467b-8b1d-4fbe1404f1f318
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY4ca5555d-fd45-467b-8b1d-4fbe1404f1f318

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-982-104306309821010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-982-10) 2019-08-080000-00-00NoNoCurrent
43063-982-304306309823030 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-982-30) 2019-05-010000-00-00NoNoCurrent