FDA.reportPublic FDA data

Sildenafil Citrate

Product NDC
72888-018
11-digit product format
728880018
Labeler code
72888
Product ID
72888-018_4844bbd3-43cc-de26-e063-6394a90ab584
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Advagen Pharma Ltd
Application
ANDA204883
Marketing category
ANDA
Marketing start
2016-08-01
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
2027-12-31
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 CITRATE20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiBW9B0ZE037
Rxcui577033

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
72888-018-00Sildenafil Citrate1000 in 1 BOTTLETABLET, FILM COATED10002
72888-018-90Sildenafil Citrate90 in 1 BOTTLETABLET, FILM COATED902

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72888-018-00EA - Each72888-018feefa0ba-933d-40cb-86e7-31994ed4c49312022-04-06
72888-018-90EA - Each72888-01828d79d5a-477d-4b1f-aaab-569107cfb18b12021-07-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72888-018SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [ADVAGEN PHARMA LTD]1Current NDC, Legacy NDC, 2 package rows20210414_ce683bbc-a1d2-4f23-b3d1-d9333d91dc55.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN88825206-1b91-4d95-876c-71100912d3784
577033sildenafil 20 MG Oral TabletSCD88825206-1b91-4d95-876c-71100912d3784
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY88825206-1b91-4d95-876c-71100912d3784
577033sildenafil citrate 20 MG Oral TabletPSN471b8574-cb2a-1670-e063-6394a90a2a842
577033sildenafil citrate 20 MG Oral TabletPSNce683bbc-a1d2-4f23-b3d1-d9333d91dc552
577033sildenafil 20 MG Oral TabletSCD471b8574-cb2a-1670-e063-6394a90a2a842
577033sildenafil 20 MG Oral TabletSCDce683bbc-a1d2-4f23-b3d1-d9333d91dc552
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY471b8574-cb2a-1670-e063-6394a90a2a842
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYce683bbc-a1d2-4f23-b3d1-d9333d91dc552

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
72888-018-00728880018001000 TABLET, FILM COATED in 1 BOTTLE (72888-018-00) 2021-03-050000-00-00NoNoCurrent
72888-018-907288800189090 TABLET, FILM COATED in 1 BOTTLE (72888-018-90) 2021-03-050000-00-00NoNoCurrent