FDA.reportPublic FDA data

Sildenafil

Product NDC
13668-185
11-digit product format
136680185
Labeler code
13668
Product ID
13668-185_8b584f5d-8030-4f91-a129-8120f9e1b204
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Torrent Pharmaceuticals Limited
Application
ANDA091479
Marketing category
ANDA
Marketing start
2012-11-06
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
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
13668-185-05Sildenafil500 in 1 BOTTLETABLET, FILM COATED50020
13668-185-10Sildenafil1000 in 1 BOTTLETABLET, FILM COATED100020
13668-185-30Sildenafil30 in 1 BOTTLETABLET, FILM COATED3020
13668-185-51Sildenafil5000 in 1 BOTTLETABLET, FILM COATED500020
13668-185-90Sildenafil90 in 1 BOTTLETABLET, FILM COATED9020

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
13668-185-05EA - Each13668-1857547c695-4a00-4170-9aff-60944a8e745f12013-02-13
13668-185-90EA - Each13668-1857c13af64-f510-4f11-be6a-869bf10185c012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
ANHYDROUS DIBASIC CALCIUM PHOSPHATEINACTIVE INGREDIENTL11K75P92JSILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
HYPROMELLOSE 2910 (6 MPA.S)INACTIVE INGREDIENT0WZ8WG20P6SILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
SODIUM STEARYL FUMARATEINACTIVE INGREDIENT7CV7WJK4UISILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL CITRATE TABLET [TORRENT PHARMACEUTICALS LIMITED]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13668-185SILDENAFIL TABLET, FILM COATED [TORRENT PHARMACEUTICALS LIMITED]17Current NDC, Legacy NDC, 5 package rows20250209_1bc081f2-399d-43fa-9e0f-9f8df0118e99.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil 20 MG Oral TabletSCD1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY1bc081f2-399d-43fa-9e0f-9f8df0118e9920
577033sildenafil citrate 20 MG Oral TabletPSNa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil 20 MG Oral TabletSCDa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa65b5fb3-ca3c-4226-9caa-42fb9a2f73739
577033sildenafil citrate 20 MG Oral TabletPSN28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG Oral TabletSCD28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY28a3376b-e50e-4789-9916-803ba29a15225
577033sildenafil citrate 20 MG Oral TabletPSNf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil citrate 20 MG Oral TabletPSNa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG Oral TabletSCDa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG Oral TabletSCDf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYa9599ede-632f-436b-9b74-feb98e77ff1b2
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYf925abbe-4977-00b0-e053-6294a90a6e532
577033sildenafil citrate 20 MG Oral TabletPSN49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil citrate 20 MG Oral TabletPSN71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil citrate 20 MG Oral TabletPSN48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil citrate 20 MG Oral TabletPSN486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG Oral TabletSCD48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG Oral TabletSCD49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil 20 MG Oral TabletSCD71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG Oral TabletSCD486dcfc4-f07a-4a78-86f0-f1c5ae448dc11
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY49a95b25-08b3-4cfe-a60b-c5132c280be21
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY71140bd5-0a51-4c01-ad0d-193d08ea67dd1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY48c56418-0e45-083f-e063-6294a90a57b31
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY486dcfc4-f07a-4a78-86f0-f1c5ae448dc11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
13668-185-0513668018505500 TABLET, FILM COATED in 1 BOTTLE (13668-185-05) 2012-11-060000-00-00NoNoCurrent
13668-185-10136680185101000 TABLET, FILM COATED in 1 BOTTLE (13668-185-10) 2024-12-04NoNoCurrent
13668-185-301366801853030 TABLET, FILM COATED in 1 BOTTLE (13668-185-30) 2012-11-060000-00-00NoNoCurrent
13668-185-51136680185515000 TABLET, FILM COATED in 1 BOTTLE (13668-185-51) 2012-11-060000-00-00NoNoCurrent
13668-185-7413668018574100 TABLET in 1 CARTON (13668-185-74) 100 tablet2012-11-060000-00-00NoNoCurrent
13668-185-901366801859090 TABLET, FILM COATED in 1 BOTTLE (13668-185-90) 2012-11-060000-00-00NoNoCurrent