FDA.reportPublic FDA data

Sildenafil

Product NDC
0093-5343
11-digit product format
000935343
Labeler code
0093
Product ID
0093-5343_f85e5bfc-be48-4675-8867-1585f412ccb6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Sildenafil
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA077342
Marketing category
ANDA
Marketing start
2017-12-11
Substance
SILDENAFIL CITRATE
Active strength
100 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 CITRATE100 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
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
ac996ae9-22a2-41c2-bb86-913c4aef95adProduct name120230606
fc95c9f0-00dc-40ef-bcea-b60c9009c5fcProduct name920220613
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-5343-01Sildenafil100 in 1 BOTTLETABLET, FILM COATED1008
0093-5343-56Sildenafil30 in 1 BOTTLETABLET, FILM COATED308

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-5343-01EA - Each0093-534380cf1f5a-dd92-41b4-b12e-009c1a6c260212018-01-12
0093-5343-56EA - Each0093-53431a9eb538-53ca-4898-a84c-12e3566dfe4612018-01-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-5343SILDENAFIL TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]8Current NDC, Legacy NDC, 2 package rows20241025_5cbac450-f336-45bd-8d10-9ecfd21866eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
314229sildenafil citrate 100 MG Oral TabletPSNf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG Oral TabletSCDf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSYf9ab796c-1912-4137-abec-e8336a850a58101
314229sildenafil citrate 100 MG Oral TabletPSN5cbac450-f336-45bd-8d10-9ecfd21866eb8
314228sildenafil citrate 25 MG Oral TabletPSN5cbac450-f336-45bd-8d10-9ecfd21866eb8
312950sildenafil citrate 50 MG Oral TabletPSN5cbac450-f336-45bd-8d10-9ecfd21866eb8
314229sildenafil 100 MG Oral TabletSCD5cbac450-f336-45bd-8d10-9ecfd21866eb8
314228sildenafil 25 MG Oral TabletSCD5cbac450-f336-45bd-8d10-9ecfd21866eb8
312950sildenafil 50 MG Oral TabletSCD5cbac450-f336-45bd-8d10-9ecfd21866eb8
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY5cbac450-f336-45bd-8d10-9ecfd21866eb8
314228sildenafil 25 MG (as sildenafil citrate) Oral TabletSY5cbac450-f336-45bd-8d10-9ecfd21866eb8
312950sildenafil 50 MG (as sildenafil citrate) Oral TabletSY5cbac450-f336-45bd-8d10-9ecfd21866eb8
314229sildenafil citrate 100 MG Oral TabletPSN43a036a4-8a34-4411-ac8e-bf5063d67d485
314229sildenafil 100 MG Oral TabletSCD43a036a4-8a34-4411-ac8e-bf5063d67d485
314229sildenafil 100 MG (as sildenafil citrate) Oral TabletSY43a036a4-8a34-4411-ac8e-bf5063d67d485

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-5343-0100093534301100 TABLET, FILM COATED in 1 BOTTLE (0093-5343-01) 2017-12-110000-00-00NoNoCurrent
0093-5343-560009353435630 TABLET, FILM COATED in 1 BOTTLE (0093-5343-56) 2017-12-110000-00-00NoNoCurrent