FDA.reportPublic FDA data

VARDENAFIL HYDROCHLORIDE

Product NDC
46708-236
11-digit product format
467080236
Labeler code
46708
Product ID
46708-236_f87ba545-36e3-4d7d-aa52-3976a44e1719
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL HYDROCHLORIDE
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA214031
Marketing category
ANDA
Marketing start
2020-08-05
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
2.5 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 HYDROCHLORIDE2.5 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
46708-236-30VARDENAFIL HYDROCHLORIDE30 in 1 BOTTLETABLET, FILM COATED302
46708-236-31VARDENAFIL HYDROCHLORIDE100 in 1 BOTTLETABLET, FILM COATED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46708-236VARDENAFIL HYDROCHLORIDE TABLET, FILM COATED [ALEMBIC PHARMACEUTICALS LIMITED]2Current NDC, Legacy NDC, 2 package rows20230125_9b8da728-8f52-4c1f-9f0c-4bd9736e912f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349478vardenafil 5 MG Oral TabletPSN9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349479vardenafil HCl 10 MG Oral TabletPSN9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
402273vardenafil HCl 2.5 MG Oral TabletPSN9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349479vardenafil 10 MG Oral TabletSCD9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
402273vardenafil 2.5 MG Oral TabletSCD9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349480vardenafil 20 MG Oral TabletSCD9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349478vardenafil 5 MG Oral TabletSCD9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY9b8da728-8f52-4c1f-9f0c-4bd9736e912f2
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY9b8da728-8f52-4c1f-9f0c-4bd9736e912f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
46708-236-304670802363030 TABLET, FILM COATED in 1 BOTTLE (46708-236-30) 2020-08-050000-00-00NoNoCurrent
46708-236-3146708023631100 TABLET, FILM COATED in 1 BOTTLE (46708-236-31) 2020-08-050000-00-00NoNoCurrent