FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
43063-940
11-digit product format
430630940
Labeler code
43063
Product ID
43063-940_32d712de-80d4-61a5-e063-6294a90a0f30
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA091448
Marketing category
ANDA
Marketing start
2018-06-11
Substance
SILDENAFIL CITRATE
Active strength
100 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 CITRATE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILDENAFIL CITRATE100 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui314229

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
43063-940-10SILDENAFIL CITRATE10 in 1 BOTTLE, PLASTICTABLET, FILM COATED1019
43063-940-15SILDENAFIL CITRATE15 in 1 BOTTLE, PLASTICTABLET, FILM COATED1519

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-940-10EA - Each43063-940b061b16e-adac-4d29-ae7d-83332c641c7312019-07-02
43063-940-15EA - Each43063-9408be32709-4799-4c61-b07f-ad66b24dcf1612019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43063-940SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.]18Current NDC, Legacy NDC, 2 package rows20250417_ace2bb56-4992-49fe-9311-535b12eea9b4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNace2bb56-4992-49fe-9311-535b12eea9b419
314229sildenafil 100 MG Oral TabletSCDace2bb56-4992-49fe-9311-535b12eea9b419
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYace2bb56-4992-49fe-9311-535b12eea9b419

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43063-940-104306309401010 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-940-10) 2019-05-160000-00-00NoNoCurrent
43063-940-154306309401515 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-940-15) 2019-01-300000-00-00NoNoCurrent