FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
75834-272
11-digit product format
758340272
Labeler code
75834
Product ID
75834-272_506bb4eb-697e-9d05-e063-6294a90a8f2c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL CITRATE
Dosage form
TABLET
Route
ORAL
Labeler
NIVAGEN PHARMACEUTICALS, INC.
Application
ANDA209302
Marketing category
ANDA
Marketing start
2021-06-16
Substance
SILDENAFIL CITRATE
Active strength
25 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 CITRATE25 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
75834-272-00SILDENAFIL CITRATE1000 in 1 BOTTLETABLET100014
75834-272-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET3014
75834-272-90SILDENAFIL CITRATE90 in 1 BOTTLETABLET9014

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
75834-272-00EA - Each75834-272d79e5169-a73a-4dfd-b960-e0f78e98100c12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75834-272SILDENAFIL CITRATE TABLET [NIVAGEN PHARMACEUTICALS, INC.]11Current NDC, Legacy NDC, 3 package rows20241225_5ac95dd0-57e4-495c-bf8d-b2e5bbe33e20.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil citrate 25 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil citrate 50 MG Oral TabletPSN5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314229sildenafil 100 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil 25 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil 50 MG Oral TabletSCD5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY5ac95dd0-57e4-495c-bf8d-b2e5bbe33e2014
314228sildenafil citrate 25 MG Oral TabletPSN00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b12
314228sildenafil 25 MG Oral TabletSCD00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b12
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY00ee09dd-2de0-4dc4-85f6-b51ed6eabd5b12
314228sildenafil citrate 25 MG Oral TabletPSN1add0cab-8873-4cd1-ab53-e05c4ac458b11
314228sildenafil 25 MG Oral TabletSCD1add0cab-8873-4cd1-ab53-e05c4ac458b11
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY1add0cab-8873-4cd1-ab53-e05c4ac458b11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
75834-272-00758340272001000 TABLET in 1 BOTTLE (75834-272-00) 1000 tablet2021-06-160000-00-00NoNoCurrent
75834-272-307583402723030 TABLET in 1 BOTTLE (75834-272-30) 30 tablet2021-06-160000-00-00NoNoCurrent
75834-272-907583402729090 TABLET in 1 BOTTLE (75834-272-90) 90 tablet2021-06-160000-00-00NoNoCurrent