Levitra

Product NDC
0173-0831
11-digit product format
001730831
Labeler code
0173
Product ID
0173-0831_084e9ed5-726f-4bf4-8b51-34687f75cbed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
vardenafil hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
GlaxoSmithKline LLC
Application
NDA021400
Marketing category
NDA
Marketing start
2003-08-25
Marketing end
2021-10-31
Substance
VARDENAFIL HYDROCHLORIDE
Active strength
20 mg/1
Pharmacologic classes
Phosphodiesterase 5 Inhibitor [EPC],Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag
No
Listing certified through
0000-00-00
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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0831-13EA - Each0173-0831d04ec557-fe17-43b4-b752-5a9aac7b418512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
VARDENAFIL HYDROCHLORIDEACTIVE INGREDIENT5M8S2CU0TSLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
VARDENAFILACTIVE MOIETYUCE6F4125HLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61ULEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
CROSPOVIDONEINACTIVE INGREDIENT68401960MKLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FERRIC OXIDE REDINACTIVE INGREDIENT1K09F3G675LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRTLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
POLYETHYLENE GLYCOLINACTIVE INGREDIENT3WJQ0SDW1ALEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4LEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPLEVITRA (VARDENAFIL HYDROCHLORIDE) TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, INC.]1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
404638LEVITRA 10 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
404639LEVITRA 20 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
404637LEVITRA 5 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
349480vardenafil 20 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
349478vardenafil 5 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
349479vardenafil HCl 10 MG Oral TabletPSN4e66ad5c-572c-4819-8b6e-6930c33cc2101
404638vardenafil 10 MG Oral Tablet [Levitra]SBD4e66ad5c-572c-4819-8b6e-6930c33cc2101
404639vardenafil 20 MG Oral Tablet [Levitra]SBD4e66ad5c-572c-4819-8b6e-6930c33cc2101
404637vardenafil 5 MG Oral Tablet [Levitra]SBD4e66ad5c-572c-4819-8b6e-6930c33cc2101
349479vardenafil 10 MG Oral TabletSCD4e66ad5c-572c-4819-8b6e-6930c33cc2101
349480vardenafil 20 MG Oral TabletSCD4e66ad5c-572c-4819-8b6e-6930c33cc2101
349478vardenafil 5 MG Oral TabletSCD4e66ad5c-572c-4819-8b6e-6930c33cc2101
404639Levitra (as vardenafil HCl) 20 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
404638Levitra (as vardenafil hydrochloride) 10 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
404637Levitra (as vardenafil hydrochloride) 5 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
404638Levitra 10 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
404639Levitra 20 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
404637Levitra 5 MG Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
349479vardenafil 10 MG (vardenafil HCl 11.85 MG) Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
349480vardenafil 20 MG (vardenafil HCl 23.7 MG) Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101
349478vardenafil 5 MG (vardenafil hydrochloride 5.926 MG) Oral TabletSY4e66ad5c-572c-4819-8b6e-6930c33cc2101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0173-0831-130017308311330 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (0173-0831-13) 2003-08-252021-10-31NoNoCurrent
0173-0831-61001730831611 BLISTER PACK in 1 CARTON (0173-0831-61) > 2 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2003-08-252021-10-31NoNoCurrent