Valacyclovir

Product NDC: 52343-052
11-digit product format: 523430052
Labeler code: 52343
Product ID: 52343-052_d6adb9f0-31da-4a25-aaaf-443f16660755
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: valacyclovir hydrochloride
Dosage form: TABLET, FILM COATED
Route: ORAL
Labeler: ACETRIS HEALTH, LLC
Application: ANDA090682
Marketing category: ANDA
Marketing start: 2010-05-24
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 NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52343-052-30	EA - Each	52343-052	a570877e-1c5c-4e56-a457-67f0368017ae	1	2014-02-04
52343-052-90	EA - Each	52343-052	296efb6b-cfff-4673-a1b7-844f079e87f5	1	2014-02-04

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G447S0T1VC	VALACYCLOVIR HYDROCHLORIDE	124832-27-5	VALACYCLOVIR HYDROCHLORIDE

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
52343-052-30	52343005230	30 TABLET, FILM COATED in 1 BOTTLE (52343-052-30)	2010-05-24	0000-00-00	No	No	Current
52343-052-90	52343005290	90 TABLET, FILM COATED in 1 BOTTLE (52343-052-90)	2010-05-24	0000-00-00	No	No	Current