Home NDC 59746-324 valacyclovir hydrochloride
Product NDC 59746-324
11-digit product format 597460324
Labeler code 59746
Product ID 59746-324_40211dd2-c21e-45a4-a8d4-04febf925f52
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Jubilant Cadista Pharmaceuticals Inc.
Application ANDA201506
Marketing category ANDA
Marketing start 2012-04-05
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 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base valacyclovir hydrochloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 500 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii G447S0T1VC Rxcui 313564, 313565
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 59746-324-01 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-10 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-30 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-37 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-47 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-90 2023-02-27 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-01 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-10 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-30 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-37 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-47 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995 59746-324-90 2023-01-30 C162847 48780-1 f386c649-bac0-0266-e053-dadaa90a7c1a These highlights do not include all the information needed to use VALACYCLOVIR TABLETS safely and effectively. See full prescribing information for VALACYCLOVIR TABLETS. VALACYCLOVIR tablets, for oral use Initial U.S. Approval: 1995
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59746-324-01 valacyclovir hydrochloride 100 in 1 BOTTLE TABLET, FILM COATED 100 15 59746-324-10 valacyclovir hydrochloride 10 in 1 BOTTLE TABLET, FILM COATED 10 15 59746-324-30 valacyclovir hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 15 59746-324-37 valacyclovir hydrochloride 250 in 1 BOTTLE TABLET, FILM COATED 250 15 59746-324-47 valacyclovir hydrochloride 300 in 1 BOTTLE TABLET, FILM COATED 300 15 59746-324-90 valacyclovir hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 15
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Acyclovir ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE (VALACYCLOVIR HYDROCHLORIDE) TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 3 Valacyclovir Hydrochloride ACTIVE INGREDIENT G447S0T1VC DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 ACYCLOVIR ACTIVE MOIETY X4HES1O11F DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP DIRECT RX (VALACYCLOVIR) TABLET [DIRECT RX] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 59746-324 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [JUBILANT CADISTA PHARMACEUTICALS INC.] 15 Current NDC, Legacy NDC, 6 package rows 20230904_3277c17e-f953-2b0a-fe0a-4f5d1aeace9d.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 59746-324-01 59746032401 100 TABLET, FILM COATED in 1 BOTTLE (59746-324-01) 2012-04-05 0000-00-00 No No Current 59746-324-10 59746032410 10 TABLET, FILM COATED in 1 BOTTLE (59746-324-10) 2012-04-05 0000-00-00 No No Current 59746-324-30 59746032430 30 TABLET, FILM COATED in 1 BOTTLE (59746-324-30) 2012-04-05 0000-00-00 No No Current 59746-324-37 59746032437 250 TABLET, FILM COATED in 1 BOTTLE (59746-324-37) 2012-04-05 0000-00-00 No No Current 59746-324-47 59746032447 300 TABLET, FILM COATED in 1 BOTTLE (59746-324-47) 2012-04-05 0000-00-00 No No Current 59746-324-90 59746032490 90 TABLET, FILM COATED in 1 BOTTLE (59746-324-90) 2012-04-05 0000-00-00 No No Current