FDA.reportPublic FDA data

VARDENAFIL

Product NDC
70710-1071
11-digit product format
707101071
Labeler code
70710
Product ID
70710-1071_a6417d62-c65a-49a5-a3c7-d9d178a36cb9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Pharmaceuticals USA Inc.
Application
ANDA208960
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
VARDENAFIL
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARDENAFIL HYDROCHLORIDE TRIHYDRATE20 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
70710-1071-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1006
70710-1071-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED306
70710-1071-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED906

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70710-1071-3EA - Each70710-107138d2e268-a751-480a-b977-be5bac5ad2eb12018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70710-1071VARDENAFIL TABLET, FILM COATED [ZYDUS PHARMACEUTICALS USA INC.]5Current NDC, Legacy NDC, 3 package rows20230613_5876e062-e604-42a7-99c3-5da30b8dac06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil HCl 10 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil HCl 2.5 MG Oral TabletPSN5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil 10 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil 2.5 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349480vardenafil 20 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG Oral TabletSCD5876e062-e604-42a7-99c3-5da30b8dac066
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY5876e062-e604-42a7-99c3-5da30b8dac066
349480vardenafil 20 MG Oral TabletPSNc70a9c8e-46b0-489d-bbda-2d7fca4b629f2
349480vardenafil 20 MG Oral TabletSCDc70a9c8e-46b0-489d-bbda-2d7fca4b629f2
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSYc70a9c8e-46b0-489d-bbda-2d7fca4b629f2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70710-1071-170710107101100 TABLET, FILM COATED in 1 BOTTLE (70710-1071-1) 2018-11-010000-00-00NoNoCurrent
70710-1071-37071010710330 TABLET, FILM COATED in 1 BOTTLE (70710-1071-3) 2018-11-010000-00-00NoNoCurrent
70710-1071-97071010710990 TABLET, FILM COATED in 1 BOTTLE (70710-1071-9) 2018-11-010000-00-00NoNoCurrent