FDA.reportPublic FDA data

Sildenafil

Product NDC
71205-542
11-digit product format
712050542
Labeler code
71205
Product ID
71205-542_310f4dca-236e-4b4c-8b3c-fad143eaf9bf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA202659
Marketing category
ANDA
Marketing start
2018-06-11
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
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
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
71205-542-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED302
71205-542-60Sildenafil60 in 1 BOTTLETABLET, FILM COATED602
71205-542-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71205-542-30EA - Each71205-542f607a800-592c-48fe-8ac1-63759629850912021-06-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71205-542SILDENAFIL TABLET, FILM COATED [PROFICIENT RX LP]2Current NDC, Legacy NDC, 3 package rows20220426_5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSN5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2
312950sildenafil 50 MG Oral TabletSCD5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY5a14da46-a3ac-495f-bd9c-6e46d1ba6d7c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71205-542-307120505423030 TABLET, FILM COATED in 1 BOTTLE (71205-542-30) 2021-03-110000-00-00NoNoCurrent
71205-542-607120505426060 TABLET, FILM COATED in 1 BOTTLE (71205-542-60) 2021-03-110000-00-00NoNoCurrent
71205-542-907120505429090 TABLET, FILM COATED in 1 BOTTLE (71205-542-90) 2021-03-110000-00-00NoNoCurrent