FDA.reportPublic FDA data

Sildenafil

Product NDC
33342-121
11-digit product format
333420121
Labeler code
33342
Product ID
33342-121_03d991fd-4f2c-4086-acaf-267967cff68f
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
Marketing end
2027-10-31
Substance
SILDENAFIL CITRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sildenafil

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
33342-121-10Sildenafil90 in 1 BOTTLETABLET, FILM COATED907
33342-121-12Sildenafil10 in 1 BLISTER PACKTABLET, FILM COATED107

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
33342-121-10EA - Each33342-1218d1efb65-6422-49e0-b3a8-eed057b1461b12014-06-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]3
SILDENAFIL CITRATEACTIVE INGREDIENTBW9B0ZE037SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
SILDENAFILACTIVE MOIETY3M7OB98Y7HSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENTL11K75P92JSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61USILDENAFIL TABLET, FILM COATED [DIRECTRX]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30SILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPSILDENAFIL TABLET, FILM COATED [DIRECTRX]1
TRIACETININACTIVE INGREDIENTXHX3C3X673SILDENAFIL TABLET, FILM COATED [DIRECTRX]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-121SILDENAFIL TABLET, FILM COATED [MACLEODS PHARMACEUTICALS LIMITED]7Current NDC, Legacy NDC, 2 package rows20230812_d2892f4b-f5ba-42f5-b373-310241f4efa7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
577033sildenafil citrate 20 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil citrate 50 MG Oral TabletPSN3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG Oral TabletSCD3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY3b3aae0f-4d1d-0244-e054-00144ff88e8811
577033sildenafil citrate 20 MG Oral TabletPSNb812890c-41a1-4f72-a06a-b550a0ca034e8
577033sildenafil citrate 20 MG Oral TabletPSN46dff4c0-9a6c-20f9-e054-00144ff8d46c8
577033sildenafil 20 MG Oral TabletSCDb812890c-41a1-4f72-a06a-b550a0ca034e8
577033sildenafil 20 MG Oral TabletSCD46dff4c0-9a6c-20f9-e054-00144ff8d46c8
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYb812890c-41a1-4f72-a06a-b550a0ca034e8
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY46dff4c0-9a6c-20f9-e054-00144ff8d46c8
577033sildenafil citrate 20 MG Oral TabletPSNd2892f4b-f5ba-42f5-b373-310241f4efa77
577033sildenafil 20 MG Oral TabletSCDd2892f4b-f5ba-42f5-b373-310241f4efa77
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYd2892f4b-f5ba-42f5-b373-310241f4efa77
577033sildenafil citrate 20 MG Oral TabletPSN72900ed9-dbab-3f7b-e053-2a91aa0a0d245
577033sildenafil 20 MG Oral TabletSCD72900ed9-dbab-3f7b-e053-2a91aa0a0d245
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY72900ed9-dbab-3f7b-e053-2a91aa0a0d245
577033sildenafil citrate 20 MG Oral TabletPSN0a9ec226-572a-47f1-aea1-514615b2b6ed4
577033sildenafil citrate 20 MG Oral TabletPSN7c01fd56-5dd6-4728-9f2a-e0f5db8102694
577033sildenafil 20 MG Oral TabletSCD0a9ec226-572a-47f1-aea1-514615b2b6ed4
577033sildenafil 20 MG Oral TabletSCD7c01fd56-5dd6-4728-9f2a-e0f5db8102694
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY0a9ec226-572a-47f1-aea1-514615b2b6ed4
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7c01fd56-5dd6-4728-9f2a-e0f5db8102694
577033sildenafil citrate 20 MG Oral TabletPSN2538995d-2df6-4c87-978a-5513c670b60f3
577033sildenafil citrate 20 MG Oral TabletPSN85767ed7-932b-4e2b-8bba-b59bb45ce1163
577033sildenafil citrate 20 MG Oral TabletPSN97ccea8a-6d5a-129f-e053-2995a90aa8373
577033sildenafil 20 MG Oral TabletSCD85767ed7-932b-4e2b-8bba-b59bb45ce1163
577033sildenafil 20 MG Oral TabletSCD97ccea8a-6d5a-129f-e053-2995a90aa8373
577033sildenafil 20 MG Oral TabletSCD2538995d-2df6-4c87-978a-5513c670b60f3
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY97ccea8a-6d5a-129f-e053-2995a90aa8373
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY85767ed7-932b-4e2b-8bba-b59bb45ce1163
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY2538995d-2df6-4c87-978a-5513c670b60f3
577033sildenafil citrate 20 MG Oral TabletPSN06571775-b651-4e23-a35b-88392aae7e132
577033sildenafil 20 MG Oral TabletSCD06571775-b651-4e23-a35b-88392aae7e132
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY06571775-b651-4e23-a35b-88392aae7e132
577033sildenafil citrate 20 MG Oral TabletPSN7dc93e98-6c6f-c094-e053-2991aa0a19fc1
577033sildenafil citrate 20 MG Oral TabletPSN74ee9b44-aa9d-43af-88f7-da7e31ea00051
577033sildenafil citrate 20 MG Oral TabletPSN6939f4cc-45d8-45b7-8fd9-9d384aa43a5a1
577033sildenafil citrate 20 MG Oral TabletPSNc152953d-53a0-4f8b-91d7-fcd94024ad491
577033sildenafil 20 MG Oral TabletSCD7dc93e98-6c6f-c094-e053-2991aa0a19fc1
577033sildenafil 20 MG Oral TabletSCD74ee9b44-aa9d-43af-88f7-da7e31ea00051
577033sildenafil 20 MG Oral TabletSCD6939f4cc-45d8-45b7-8fd9-9d384aa43a5a1
577033sildenafil 20 MG Oral TabletSCDc152953d-53a0-4f8b-91d7-fcd94024ad491
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY7dc93e98-6c6f-c094-e053-2991aa0a19fc1
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY74ee9b44-aa9d-43af-88f7-da7e31ea00051
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSYc152953d-53a0-4f8b-91d7-fcd94024ad491
577033sildenafil 20 MG (as sildenafil citrate) Oral TabletSY6939f4cc-45d8-45b7-8fd9-9d384aa43a5a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
33342-121-103334201211090 TABLET, FILM COATED in 1 BOTTLE (33342-121-10) 2014-01-032027-10-31NoNoCurrent
33342-121-123334201211210 TABLET, FILM COATED in 1 BLISTER PACK (33342-121-12) 2014-01-032027-10-31NoNoCurrent