FDA.reportPublic FDA data

Valacyclovir hydrochloride

Product NDC
71335-0123
11-digit product format
713350123
Labeler code
71335
Product ID
71335-0123_f16a9466-f381-40ba-aa6f-36854837af01
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077135
Marketing category
ANDA
Marketing start
2010-05-24
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1000 mg/1
Pharmacologic classes
DNA Polymerase Inhibitors [MoA], Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor [EPC], Nucleoside Analog [EXT]
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
71335-0123-1EA - Each71335-0123ef4e7105-f801-4e8b-8ec2-a850ad5bd8f312018-03-08
71335-0123-2EA - Each71335-0123c2b7d960-1073-435d-a1f3-6116a1fa28c212018-03-08
71335-0123-3EA - Each71335-0123bd227285-fbc4-435b-9f06-e09e0eae124812018-03-08
71335-0123-4EA - Each71335-01233b8c785e-7f7f-478f-9736-bf71b42625bf12018-03-08
71335-0123-5EA - Each71335-012326b8b0e9-9da1-49b0-afbc-2868f0e144c212018-03-08
71335-0123-6EA - Each71335-01233734e63b-4d37-4c3e-b925-9ccdee21ec8312018-03-08
71335-0123-7EA - Each71335-0123caae9fe4-d49c-467f-b89e-8ef3dcf7115e12018-03-08
71335-0123-8EA - Each71335-0123a584b696-2743-4c14-a0b8-6037b411d13312018-03-08

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-0123-07133501230060 TABLET in 1 BOTTLE (71335-0123-0) 60 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-17133501230130 TABLET in 1 BOTTLE (71335-0123-1) 30 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-27133501230221 TABLET in 1 BOTTLE (71335-0123-2) 21 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-37133501230320 TABLET in 1 BOTTLE (71335-0123-3) 20 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-4713350123044 TABLET in 1 BOTTLE (71335-0123-4) 4 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-57133501230510 TABLET in 1 BOTTLE (71335-0123-5) 10 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-6713350123066 TABLET in 1 BOTTLE (71335-0123-6) 6 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-77133501230715 TABLET in 1 BOTTLE (71335-0123-7) 15 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-8713350123088 TABLET in 1 BOTTLE (71335-0123-8) 8 tablet2017-01-250000-00-00NoNoCurrent
71335-0123-97133501230990 TABLET in 1 BOTTLE (71335-0123-9) 90 tablet2017-01-250000-00-00NoNoCurrent