FDA.reportPublic FDA data

Sildenafil

Product NDC
33342-536
11-digit product format
333420536
Labeler code
33342
Product ID
33342-536_d9ad8c65-3264-44dc-b6f9-bdef8467cdad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
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
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
33342-536-10Sildenafil90 in 1 BOTTLETABLET, FILM COATED906
33342-536-66Sildenafil10 in 1 BLISTER PACKTABLET, FILM COATED106

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-536-10EA - Each33342-5366db16db5-69fa-4e4f-a1db-2030e32b507b12024-12-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-536SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3Current NDC, 2 package rows20240907_61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e6
577033sildenafil 20 MG Oral TabletSCD61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e6
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY61a0ebd9-8dc9-4bcc-b07b-f3d6398ea96e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
33342-536-103334205361090 TABLET, FILM COATED in 1 BOTTLE (33342-536-10) 2014-01-03NoNoHistorical
33342-536-663334205366610 TABLET, FILM COATED in 1 BLISTER PACK (33342-536-66) 2014-01-03NoNoHistorical