FDA.reportPublic FDA data

Vardenafil Hydrochloride

Product NDC
73750-104
11-digit product format
737500104
Labeler code
73750
Product ID
73750-104_db8e52bb-02ac-9e93-e053-2a95a90a7c85
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Vardenafil Hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
QYK BRANDS LLC
Application
ANDA204632
Marketing category
ANDA
Marketing start
2022-03-01
Marketing end
0000-00-00
Substance
VARDENAFIL
Active strength
10 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73750-104-102023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-104-112023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003
73750-104-302023-07-28C16284748780-10191ceaa-65ee-198a-e063-dbdaa90aec3eThese highlights do not include all the information needed to use Vardenafil Hydrochloride Tablets safely and effectively. See full prescribing information for Vardenafil Hydrochloride Tablets. VARDENAFIL HYDROCHLORIDE Tablets, for oral use Initial U.S. Approval: 2003

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73750-104-10Vardenafil Hydrochloride100 in 1 BOTTLETABLET1002
73750-104-11Vardenafil Hydrochloride10 in 1 BLISTER PACKTABLET102
73750-104-11Vardenafil Hydrochloride10 in 1 CARTONTABLET102
73750-104-30Vardenafil Hydrochloride30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73750-104VARDENAFIL HYDROCHLORIDE TABLET [QYK BRANDS LLC]2Legacy NDC, 4 package rows20220402_db63310a-37f3-202b-e053-2995a90a5520.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
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
73750-104-1073750010410100 TABLET in 1 BOTTLE (73750-104-10) 100 tablet2022-03-010000-00-00NoNoCurrent
73750-104-117375001041110 BLISTER PACK in 1 CARTON (73750-104-11) > 10 TABLET in 1 BLISTER PACK10 blister pack2022-03-010000-00-00NoNoCurrent
73750-104-307375001043030 TABLET in 1 BOTTLE (73750-104-30) 30 tablet2022-03-010000-00-00NoNoCurrent