Home NDC 63304-904 Valacyclovir
Product NDC 63304-904
11-digit product format 633040904
Labeler code 63304
Product ID 63304-904_744b60c8-568b-4726-881c-68709c30f28a
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir
Dosage form TABLET, FILM COATED
Route ORAL
Labeler SUN PHARMACEUTICAL INDUSTRIES, INC.
Application ANDA076588
Marketing category ANDA
Marketing start 2020-12-19
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
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 500 mg/1
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 63304-904-03 2020-12-19 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-05 2020-12-19 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-30 2020-12-19 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-77 2020-12-19 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-90 2020-12-19 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-03 2020-01-31 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-05 2020-01-31 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-30 2020-01-31 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-77 2020-01-31 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-90 2020-01-31 C162847 48780-1 9d75b9d0-769f-f424-e053-dadaa90a57ce 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 63304-904-03 Valacyclovir 10 in 1 BOTTLE TABLET, FILM COATED 10 18 63304-904-05 Valacyclovir 500 in 1 BOTTLE TABLET, FILM COATED 500 18 63304-904-11 Valacyclovir 1 in 1 BLISTER PACK TABLET, FILM COATED 1 18 63304-904-30 Valacyclovir 30 in 1 BOTTLE TABLET, FILM COATED 30 18 63304-904-77 Valacyclovir 100 in 1 CARTON TABLET, FILM COATED 100 18 63304-904-90 Valacyclovir 90 in 1 BOTTLE TABLET, FILM COATED 90 18
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 ACYCLOVIR ACTIVE MOIETY X4HES1O11F VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 HYPROMELLOSES INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 POLYETHYLENE GLYCOL 400 INACTIVE INGREDIENT B697894SGQ VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 POLYETHYLENE GLYCOL 6000 INACTIVE INGREDIENT 30IQX730WE VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 POVIDONES INACTIVE INGREDIENT FZ989GH94E VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR TABLET, FILM COATED [RANBAXY PHARMACEUTICALS INC.] 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63304-904 VALACYCLOVIR TABLET, FILM COATED [SUN PHARMACEUTICAL INDUSTRIES, INC.] 17 Current NDC, Legacy NDC, 6 package rows 20231130_26634bf1-c6d8-4d48-9a4e-845c47df07f8.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 63304-904-03 63304090403 10 TABLET, FILM COATED in 1 BOTTLE (63304-904-03) 2020-12-19 0000-00-00 No No Current 63304-904-05 63304090405 500 TABLET, FILM COATED in 1 BOTTLE (63304-904-05) 2020-12-19 0000-00-00 No No Current 63304-904-11 63304090411 1 in 1 BLISTER PACK Historical 63304-904-30 63304090430 30 TABLET, FILM COATED in 1 BOTTLE (63304-904-30) 2020-12-19 0000-00-00 No No Current 63304-904-77 63304090477 100 BLISTER PACK in 1 CARTON (63304-904-77) / 1 TABLET, FILM COATED in 1 BLISTER PACK (63304-904-11) 100 blister pack 2020-12-19 0000-00-00 No No Current 63304-904-90 63304090490 90 TABLET, FILM COATED in 1 BOTTLE (63304-904-90) 2020-12-19 0000-00-00 No No Current