Home NDC 68071-3037 Valacyclovir hydrochloride
Product NDC 68071-3037
11-digit product format 680713037
Labeler code 68071
Product ID 68071-3037_d7758b3f-13e4-130f-e053-2995a90ad42b
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 2023-12-31
Current FDA listing Historical FDA.report record DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 68071-3037-1 2022-02-07 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 68071-3037-2 2022-02-07 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 68071-3037-8 2022-02-07 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 68071-3037-1 2022-01-28 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 68071-3037-2 2022-01-28 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995 68071-3037-8 2022-01-28 C162847 48780-1 d6a99b39-5405-a426-e053-dadaa90af4c2 These highlights do not include all the information needed to use VALACYCLOVIR TABLETS, USP safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS, USP. VALACYCLOVIR TABLETS, USP Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3037-1 Valacyclovir hydrochloride 10 in 1 BOTTLE TABLET 10 5 68071-3037-2 Valacyclovir hydrochloride 12 in 1 BOTTLE TABLET 12 5 68071-3037-8 Valacyclovir hydrochloride 8 in 1 BOTTLE TABLET 8 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3037 VALACYCLOVIR HYDROCHLORIDE TABLET [NUCARE PHARMACEUTICALS, INC.] 5 Legacy NDC, 3 package rows 20240720_49db4bcd-8b5a-048d-e054-00144ff88e88.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-3037-1 68071303701 10 TABLET in 1 BOTTLE (68071-3037-1) 10 tablet 2017-03-03 0000-00-00 No No Current 68071-3037-2 68071303702 12 TABLET in 1 BOTTLE (68071-3037-2) 12 tablet 2017-03-03 0000-00-00 No No Current 68071-3037-8 68071303708 8 TABLET in 1 BOTTLE (68071-3037-8) 8 tablet 2017-03-03 0000-00-00 No No Current