FDA.reportPublic FDA data

SILDENAFIL CITRATE

Product NDC
13668-186
11-digit product format
136680186
Labeler code
13668
Product ID
13668-186_e835d1de-642e-4ea7-98ff-390effd8331f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SILDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091448
Marketing category
ANDA
Marketing start
2018-06-11
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
13668-186-01SILDENAFIL CITRATE100 in 1 BOTTLETABLET, FILM COATED10015
13668-186-05SILDENAFIL CITRATE500 in 1 BOTTLETABLET, FILM COATED50015
13668-186-10SILDENAFIL CITRATE1000 in 1 BOTTLETABLET, FILM COATED100015
13668-186-30SILDENAFIL CITRATE30 in 1 BOTTLETABLET, FILM COATED3015
13668-186-40SILDENAFIL CITRATE4000 in 1 BOTTLETABLET, FILM COATED400015

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-186-30EA - Each13668-1861a3ff624-c4dc-4147-a28a-0bb2222478b412018-07-03

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-186SILDENAFIL CITRATE (SILDENAFIL) TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]14Current NDC, Legacy NDC, 5 package rows20241210_b48630b1-5208-4d00-b56f-21701f223758.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil citrate 25 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil citrate 50 MG Oral TabletPSNb48630b1-5208-4d00-b56f-21701f22375815
314229sildenafil 100 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil 25 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil 50 MG Oral TabletSCDb48630b1-5208-4d00-b56f-21701f22375815
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSYb48630b1-5208-4d00-b56f-21701f22375815

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-186-0113668018601100 TABLET, FILM COATED in 1 BOTTLE (13668-186-01) 2018-06-110000-00-00NoNoCurrent
13668-186-0513668018605500 TABLET, FILM COATED in 1 BOTTLE (13668-186-05) 2018-06-110000-00-00NoNoCurrent
13668-186-10136680186101000 TABLET, FILM COATED in 1 BOTTLE (13668-186-10) 2024-12-06NoNoCurrent
13668-186-301366801863030 TABLET, FILM COATED in 1 BOTTLE (13668-186-30) 2018-06-110000-00-00NoNoCurrent
13668-186-40136680186404000 TABLET, FILM COATED in 1 BOTTLE (13668-186-40) 2018-06-110000-00-00NoNoCurrent
13668-186-7413668018674100 BLISTER PACK in 1 CARTON (13668-186-74) > 10 TABLET, FILM COATED in 1 BLISTER PACK (13668-186-71) 100 blister pack2018-06-110000-00-00NoNoCurrent