FDA.reportPublic FDA data

VARDENAFIL HYDROCHLORIDE

Product NDC
62332-237
11-digit product format
623320237
Labeler code
62332
Product ID
62332-237_fb17a719-cf8a-4d04-885a-3908378c5216
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA214031
Marketing category
ANDA
Marketing start
2020-08-05
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
5 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 HYDROCHLORIDE5 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
9c8b57d3-6030-411c-8a17-97b4b8f0ea17Product name320200708

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
62332-237-30VARDENAFIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED308
62332-237-31VARDENAFIL HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-237VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS INC.]8Current NDC, Legacy NDC, 2 package rows20230527_d2dce236-257e-44b6-93a9-9f0280257c6a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSNd2dce236-257e-44b6-93a9-9f0280257c6a8
349478vardenafil 5 MG Oral TabletPSNd2dce236-257e-44b6-93a9-9f0280257c6a8
349479vardenafil HCl 10 MG Oral TabletPSNd2dce236-257e-44b6-93a9-9f0280257c6a8
402273vardenafil HCl 2.5 MG Oral TabletPSNd2dce236-257e-44b6-93a9-9f0280257c6a8
349479vardenafil 10 MG Oral TabletSCDd2dce236-257e-44b6-93a9-9f0280257c6a8
402273vardenafil 2.5 MG Oral TabletSCDd2dce236-257e-44b6-93a9-9f0280257c6a8
349480vardenafil 20 MG Oral TabletSCDd2dce236-257e-44b6-93a9-9f0280257c6a8
349478vardenafil 5 MG Oral TabletSCDd2dce236-257e-44b6-93a9-9f0280257c6a8
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSYd2dce236-257e-44b6-93a9-9f0280257c6a8
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSYd2dce236-257e-44b6-93a9-9f0280257c6a8
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYd2dce236-257e-44b6-93a9-9f0280257c6a8
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSYd2dce236-257e-44b6-93a9-9f0280257c6a8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
62332-237-306233202373030 TABLET, FILM COATED in 1 BOTTLE (62332-237-30) 2020-08-050000-00-00NoNoCurrent
62332-237-3162332023731100 TABLET, FILM COATED in 1 BOTTLE (62332-237-31) 2020-08-050000-00-00NoNoCurrent