FDA.reportPublic FDA data

Sildenafil

Product NDC
71335-1638
11-digit product format
713351638
Labeler code
71335
Product ID
71335-1638_68ec1574-866c-495a-a4e9-5631d24b2b04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA203814
Marketing category
ANDA
Marketing start
2014-01-03
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil
Listing expiration
2026-12-31

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
71335-1638-1Sildenafil10 in 1 BOTTLETABLET, FILM COATED103
71335-1638-2Sildenafil30 in 1 BOTTLETABLET, FILM COATED303
71335-1638-3Sildenafil7 in 1 BOTTLETABLET, FILM COATED73
71335-1638-4Sildenafil90 in 1 BOTTLETABLET, FILM COATED903
71335-1638-5Sildenafil60 in 1 BOTTLETABLET, FILM COATED603
71335-1638-6Sildenafil20 in 1 BOTTLETABLET, FILM COATED203
71335-1638-7Sildenafil270 in 1 BOTTLETABLET, FILM COATED2703
71335-1638-8Sildenafil15 in 1 BOTTLETABLET, FILM COATED153
71335-1638-9Sildenafil12 in 1 BOTTLETABLET, FILM COATED123

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1638SILDENAFIL TABLET, FILM COATED [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 9 package rows20200919_85767ed7-932b-4e2b-8bba-b59bb45ce116.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN85767ed7-932b-4e2b-8bba-b59bb45ce1163
577033sildenafil 20 MG Oral TabletSCD85767ed7-932b-4e2b-8bba-b59bb45ce1163
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY85767ed7-932b-4e2b-8bba-b59bb45ce1163

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71335-1638-17133516380110 TABLET, FILM COATED in 1 BOTTLE (71335-1638-1) 2014-01-030000-00-00NoNoCurrent
71335-1638-27133516380230 TABLET, FILM COATED in 1 BOTTLE (71335-1638-2) 2014-01-030000-00-00NoNoCurrent
71335-1638-3713351638037 TABLET, FILM COATED in 1 BOTTLE (71335-1638-3) 2014-01-030000-00-00NoNoCurrent
71335-1638-47133516380490 TABLET, FILM COATED in 1 BOTTLE (71335-1638-4) 2014-01-030000-00-00NoNoCurrent
71335-1638-57133516380560 TABLET, FILM COATED in 1 BOTTLE (71335-1638-5) 2014-01-030000-00-00NoNoCurrent
71335-1638-67133516380620 TABLET, FILM COATED in 1 BOTTLE (71335-1638-6) 2014-01-030000-00-00NoNoCurrent
71335-1638-771335163807270 TABLET, FILM COATED in 1 BOTTLE (71335-1638-7) 2014-01-030000-00-00NoNoCurrent
71335-1638-87133516380815 TABLET, FILM COATED in 1 BOTTLE (71335-1638-8) 2014-01-030000-00-00NoNoCurrent
71335-1638-97133516380912 TABLET, FILM COATED in 1 BOTTLE (71335-1638-9) 2014-01-030000-00-00NoNoCurrent