FDA.reportPublic FDA data

VARDENAFIL

Product NDC
70771-1048
11-digit product format
707711048
Labeler code
70771
Product ID
70771-1048_4fb9ca6c-4610-42f9-87f0-224d76c542f2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Zydus Lifesciences Limited
Application
ANDA208960
Marketing category
ANDA
Marketing start
2018-11-01
Substance
VARDENAFIL HYDROCHLORIDE TRIHYDRATE
Active strength
5 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 TRIHYDRATE5 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
70771-1048-1VARDENAFIL100 in 1 BOTTLETABLET, FILM COATED1007
70771-1048-3VARDENAFIL30 in 1 BOTTLETABLET, FILM COATED307
70771-1048-9VARDENAFIL90 in 1 BOTTLETABLET, FILM COATED907

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70771-1048VARDENAFIL TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]5Current NDC, Legacy NDC, 3 package rows20240817_8ea14f7e-44a0-4d9c-968a-87b97ca12f09.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
349480vardenafil 20 MG Oral TabletPSN8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349478vardenafil 5 MG Oral TabletPSN8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349479vardenafil HCl 10 MG Oral TabletPSN8ea14f7e-44a0-4d9c-968a-87b97ca12f097
402273vardenafil HCl 2.5 MG Oral TabletPSN8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349479vardenafil 10 MG Oral TabletSCD8ea14f7e-44a0-4d9c-968a-87b97ca12f097
402273vardenafil 2.5 MG Oral TabletSCD8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349480vardenafil 20 MG Oral TabletSCD8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349478vardenafil 5 MG Oral TabletSCD8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY8ea14f7e-44a0-4d9c-968a-87b97ca12f097
402273vardenafil 2.5 MG (vardenafil hydrochloride 2.96 MG) Oral TabletSY8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY8ea14f7e-44a0-4d9c-968a-87b97ca12f097
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY8ea14f7e-44a0-4d9c-968a-87b97ca12f097

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70771-1048-170771104801100 TABLET, FILM COATED in 1 BOTTLE (70771-1048-1) 2018-11-010000-00-00NoNoCurrent
70771-1048-37077110480330 TABLET, FILM COATED in 1 BOTTLE (70771-1048-3) 2018-11-010000-00-00NoNoCurrent
70771-1048-97077110480990 TABLET, FILM COATED in 1 BOTTLE (70771-1048-9) 2018-11-010000-00-00NoNoCurrent