Valacyclovir

Product NDC
68071-3624
11-digit product format
680713624
Labeler code
68071
Product ID
68071-3624_1ac7a6de-4617-c142-e063-6394a90a4d71
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Valacyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA209553
Marketing category
ANDA
Marketing start
2023-02-14
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
2026-12-31
Current FDA listing
Yes

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
G447S0T1VCVALACYCLOVIR HYDROCHLORIDE124832-27-5VALACYCLOVIR HYDROCHLORIDE
MZ1IW7Q79DVALACYCLOVIR124832-26-4Valacyclovir

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68071-3624-36807136240330 TABLET in 1 BOTTLE (68071-3624-3) 30 tablet2024-06-13NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
ValacyclovirNuCare Pharmaceuticals,Inc.2024-06-13HUMAN PRESCRIPTION DRUG LABEL1