Home NDC 50436-0153 Valacyclovir hydrochloride
Product NDC 50436-0153
11-digit product format 504360153
Labeler code 50436
Product ID 50436-0153_97b96672-f19d-4b09-93eb-556cd1bc1898
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir hydrochloride
Dosage form TABLET
Route ORAL
Labeler Unit Dose Services
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 2020-12-31
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 50436-0153-1 2021-01-29 C162847 48780-1 ba0f9c33-30de-a910-e053-dadaa90a0b85 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 50436-0153-3 2021-01-29 C162847 48780-1 ba0f9c33-30de-a910-e053-dadaa90a0b85 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 50436-0153-4 2021-01-29 C162847 48780-1 ba0f9c33-30de-a910-e053-dadaa90a0b85 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 50436-0153-5 2021-01-29 C162847 48780-1 ba0f9c33-30de-a910-e053-dadaa90a0b85 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 50436-0153-6 2021-01-29 C162847 48780-1 ba0f9c33-30de-a910-e053-dadaa90a0b85 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 50436-0153-1 Valacyclovir hydrochloride 30 in 1 BOTTLE TABLET 30 3 50436-0153-3 Valacyclovir hydrochloride 90 in 1 BOTTLE TABLET 90 3 50436-0153-4 Valacyclovir hydrochloride 12 in 1 BOTTLE TABLET 12 3 50436-0153-5 Valacyclovir hydrochloride 15 in 1 BOTTLE TABLET 15 3 50436-0153-6 Valacyclovir hydrochloride 24 in 1 BOTTLE TABLET 24 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50436-0153 VALACYCLOVIR HYDROCHLORIDE TABLET [UNIT DOSE SERVICES] 3 Legacy NDC, 5 package rows 20190507_3331ed10-1d2b-4c88-ad2d-881f7f476198.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Status 50436-0153-1 50436015301 30 in 1 BOTTLE Historical 50436-0153-3 50436015303 90 in 1 BOTTLE Historical 50436-0153-4 50436015304 12 in 1 BOTTLE Historical 50436-0153-5 50436015305 15 in 1 BOTTLE Historical 50436-0153-6 50436015306 24 in 1 BOTTLE Historical