FDA.reportPublic FDA data

SILDENAFIL

Product NDC
72888-016
11-digit product format
728880016
Labeler code
72888
Product ID
72888-016_47c7cbb7-933e-74dc-e063-6394a90a5eb2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA204882
Marketing category
ANDA
Marketing start
2021-06-17
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, 314228, 314229

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
72888-016-00SILDENAFIL1000 in 1 BOTTLETABLET, FILM COATED10003
72888-016-01SILDENAFIL100 in 1 BOTTLETABLET, FILM COATED1003
72888-016-30SILDENAFIL30 in 1 BOTTLETABLET, FILM COATED303

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-016-00EA - Each72888-01684bae2c4-c4a9-48df-969d-f35b1d209ba112021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-016SILDENAFIL TABLET, FILM COATED [ADVAGEN PHARMA LTD]2Current NDC, Legacy NDC, 3 package rows20211110_e671d887-2317-4c1c-9b68-e24cda3d3aef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
312950sildenafil citrate 50 MG Oral TabletPSNe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5
312950sildenafil 50 MG Oral TabletSCDe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYe5ad3ce5-29ee-4b55-a67a-0f28c23a3afa5
314229sildenafil citrate 100 MG Oral TabletPSNe671d887-2317-4c1c-9b68-e24cda3d3aef3
314228sildenafil citrate 25 MG Oral TabletPSNe671d887-2317-4c1c-9b68-e24cda3d3aef3
312950sildenafil citrate 50 MG Oral TabletPSNe671d887-2317-4c1c-9b68-e24cda3d3aef3
314229sildenafil 100 MG Oral TabletSCDe671d887-2317-4c1c-9b68-e24cda3d3aef3
314228sildenafil 25 MG Oral TabletSCDe671d887-2317-4c1c-9b68-e24cda3d3aef3
312950sildenafil 50 MG Oral TabletSCDe671d887-2317-4c1c-9b68-e24cda3d3aef3
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYe671d887-2317-4c1c-9b68-e24cda3d3aef3
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYe671d887-2317-4c1c-9b68-e24cda3d3aef3
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYe671d887-2317-4c1c-9b68-e24cda3d3aef3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-016-00728880016001000 TABLET, FILM COATED in 1 BOTTLE (72888-016-00) 2021-11-080000-00-00NoNoCurrent
72888-016-0172888001601100 TABLET, FILM COATED in 1 BOTTLE (72888-016-01) 2021-06-170000-00-00NoNoCurrent
72888-016-307288800163030 TABLET, FILM COATED in 1 BOTTLE (72888-016-30) 2021-06-170000-00-00NoNoCurrent