FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
0093-7654
11-digit product format
000937654
Labeler code
0093
Product ID
0093-7654_51f4534a-5b11-490a-9e0b-ac681150967f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
ANDA091347
Marketing category
ANDA
Marketing start
2019-01-03
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
10 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
Vardenafil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE10 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5M8S2CU0TS
Rxcui349478, 349479, 349480, 402273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0093-7654-56Vardenafil Hydrochloride30 in 1 BOTTLETABLET, FILM COATED3011

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-7654VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [TEVA PHARMACEUTICALS USA, INC.]11Current NDC, Legacy NDC, 1 package rows20240125_e593ab58-70a4-4095-8091-16a4b6d49e4d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil HCl 10 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil HCl 2.5 MG Oral TabletPSNe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil 10 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil 2.5 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349480vardenafil 20 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG Oral TabletSCDe593ab58-70a4-4095-8091-16a4b6d49e4d11
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYe593ab58-70a4-4095-8091-16a4b6d49e4d11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-7654-560009376545630 TABLET, FILM COATED in 1 BOTTLE (0093-7654-56) 2019-01-030000-00-00NoNoCurrent