Valacyclovir hydrochloride

Product NDC
43063-534
11-digit product format
430630534
Labeler code
43063
Product ID
43063-534_7f9a42b1-d756-feb0-e053-2a91aa0a310f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir hydrochloride
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
PD-Rx Pharmaceuticals, Inc.
Application
ANDA090370
Marketing category
ANDA
Marketing start
2011-04-25
Marketing end
0000-00-00
Substance
VALACYCLOVIR HYDROCHLORIDE
Active strength
1 g/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
2020-12-31
Current FDA listing
Historical FDA.report record

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43063-534-04EA - Each43063-534d56feacd-e7a2-4d80-ad3f-738d6f5f61d112017-04-05
43063-534-06EA - Each43063-534adf3be51-61ba-4298-ba79-f13775c4282512014-10-03
43063-534-21EA - Each43063-53459ecb589-f2fe-442f-911f-4137f59e41cc12015-11-12