Valacyclovir hydrochloride

Product NDC
45963-558
11-digit product format
459630558
Labeler code
45963
Product ID
45963-558_04251821-ac41-4f74-acdc-96fe11febe81
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Actavis Pharma, Inc.
Application
ANDA090370
Marketing category
ANDA
Marketing start
2011-04-25
Marketing end
2019-06-30
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
500 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
0000-00-00
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45963-558-04EA - Each45963-5587ad37dd8-2996-46e7-9caa-794e2c8c119012012-07-24
45963-558-08EA - Each45963-5580788abf3-9124-4d35-8490-c86880964a2112012-07-24
45963-558-30EA - Each45963-558ee3745a9-748a-4f59-84c8-8c3d928b2f9212012-07-24