FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
33342-154
11-digit product format
333420154
Labeler code
33342
Product ID
33342-154_b02d220c-5dd4-4557-880a-7d4c0d8927b9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Macleods Pharmaceuticals Limited
Application
ANDA204632
Marketing category
ANDA
Marketing start
2019-10-24
Substance
VARDENAFIL
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
Vardenafil Hydrochloride
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiUCE6F4125H
Rxcui349478, 349479, 349480, 402273

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f15561-f1f1-39f4-fff4-873c88c535cdProduct name420210224
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
33342-154-07Vardenafil Hydrochloride30 in 1 BOTTLETABLET305
33342-154-11Vardenafil Hydrochloride100 in 1 BOTTLETABLET1005
33342-154-31Vardenafil Hydrochloride10 in 1 BLISTER PACKTABLET105
33342-154-31Vardenafil Hydrochloride5 in 1 CARTONTABLET55

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
33342-154VARDENAFIL HYDROCHLORIDE TABLET [MACLEODS PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 4 package rows20230418_a38de6e1-21ca-4ebe-a3c7-6f849cf8b675.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil HCl 10 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil HCl 2.5 MG Oral TabletPSNa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil 10 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil 2.5 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG Oral TabletSCDa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYa38de6e1-21ca-4ebe-a3c7-6f849cf8b6755
349480vardenafil 20 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil HCl 10 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil HCl 2.5 MG Oral TabletPSNdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG Oral TabletSCDdb63310a-37f3-202b-e053-2995a90a55202
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYdb63310a-37f3-202b-e053-2995a90a55202

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
33342-154-073334201540730 TABLET in 1 BOTTLE (33342-154-07) 30 tablet2019-10-240000-00-00NoNoCurrent
33342-154-1133342015411100 TABLET in 1 BOTTLE (33342-154-11) 100 tablet2019-10-240000-00-00NoNoCurrent
33342-154-31333420154315 BLISTER PACK in 1 CARTON (33342-154-31) / 10 TABLET in 1 BLISTER PACK5 blister pack2019-10-240000-00-00NoNoCurrent