Sildenafil

Product NDC
72303-0847
11-digit product format
723030847
Labeler code
72303
Product ID
72303-0847_4c5653c7-ab90-28e5-e063-6394a90af1f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
HEC Pharm USA Inc.
Application
ANDA213032
Marketing category
ANDA
Marketing start
2020-06-11
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
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 CITRATE100 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
72303-0847-1Sildenafil30 in 1 BOTTLETABLET, FILM COATED301
72303-0847-2Sildenafil100 in 1 BOTTLETABLET, FILM COATED1001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72303-0847-1EA - Each72303-084742ef201b-084f-43eb-ad21-f1b34ed8a05512026-05-22

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN4c57d855-3b49-fe6e-e063-6294a90a5cd51
314228sildenafil citrate 25 MG Oral TabletPSN4c57d855-3b49-fe6e-e063-6294a90a5cd51
312950sildenafil citrate 50 MG Oral TabletPSN4c57d855-3b49-fe6e-e063-6294a90a5cd51
314229sildenafil 100 MG Oral TabletSCD4c57d855-3b49-fe6e-e063-6294a90a5cd51
314228sildenafil 25 MG Oral TabletSCD4c57d855-3b49-fe6e-e063-6294a90a5cd51
312950sildenafil 50 MG Oral TabletSCD4c57d855-3b49-fe6e-e063-6294a90a5cd51
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY4c57d855-3b49-fe6e-e063-6294a90a5cd51
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY4c57d855-3b49-fe6e-e063-6294a90a5cd51
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY4c57d855-3b49-fe6e-e063-6294a90a5cd51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72303-0847-17230308470130 TABLET, FILM COATED in 1 BOTTLE (72303-0847-1) 2020-06-11NoNoCurrent
72303-0847-272303084702100 in 1 BOTTLEHistorical