VARDENAFIL

Product NDC
71610-643
11-digit product format
716100643
Labeler code
71610
Product ID
71610-643_872fc6c8-cdb2-4056-a5c8-874389bb6605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
VARDENAFIL
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Aphena Pharma Solutions - Tennessee, LLC
Application
ANDA208960
Marketing category
ANDA
Marketing start
2018-10-31
Marketing end
0000-00-00
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
2023-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-643-02EA - Each71610-643ad8b7bcb-12fe-4eee-aee7-7857537fbce112022-06-06
71610-643-04EA - Each71610-6432a7969cb-4d66-4ecf-9d32-dc99b622fc5e12022-06-06
71610-643-06EA - Each71610-6431c98e139-baa2-4d06-ab70-88ad4c3eb4be12022-06-06
71610-643-12EA - Each71610-643ae2e5a21-e6f7-403e-92f7-c8ccb40c2b8f12022-06-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-643VARDENAFIL TABLET, FILM COATED [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]2Legacy NDC20220512_2dde6b40-e0be-4465-bd95-061fc9a61e22.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
71610-643-02716100643022 TABLET, FILM COATED in 1 BOTTLE (71610-643-02) 2022-04-210000-00-00NoNoCurrent
71610-643-04716100643044 TABLET, FILM COATED in 1 BOTTLE (71610-643-04) 2022-04-210000-00-00NoNoCurrent
71610-643-06716100643066 TABLET, FILM COATED in 1 BOTTLE (71610-643-06) 2022-04-210000-00-00NoNoCurrent
71610-643-127161006431212 TABLET, FILM COATED in 1 BOTTLE (71610-643-12) 2022-04-210000-00-00NoNoCurrent