Valacyclovir hydrochloride

Product NDC: 68071-1842
11-digit product format: 680711842
Labeler code: 68071
Product ID: 68071-1842_bb26c010-29a4-3dc5-e053-2995a90a2c89
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Valacyclovir hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: NuCare Pharmaceuticals,Inc.
Application: ANDA077135
Marketing category: ANDA
Marketing start: 2010-05-24
Marketing end: 0000-00-00
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: 2022-12-31
Current FDA listing: Historical FDA.report record

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
68071-1842-3	2024-07-16	C162847	48780-1	ba0f9c33-3744-a910-e053-dadaa90a0b85	61fb3779-dc86-21bf-e053-2991aa0a7ada
68071-1842-3	2023-01-30	C162847	48780-1	ba0f9c33-3744-a910-e053-dadaa90a0b85	61fb3779-dc86-21bf-e053-2991aa0a7ada
68071-1842-3	2021-02-12	C162847	48780-1	ba0f9c33-3744-a910-e053-dadaa90a0b85	61fb3779-dc86-21bf-e053-2991aa0a7ada
68071-1842-3	2021-01-29	C162847	48780-1	ba0f9c33-3744-a910-e053-dadaa90a0b85	61fb3779-dc86-21bf-e053-2991aa0a7ada

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	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68071-1842-3	68071184203	30 TABLET in 1 BOTTLE (68071-1842-3)	30 tablet	2018-01-04	0000-00-00	No	No	Current