Home NDC 63187-538 valacyclovir hydrochloride
Product NDC 63187-538
11-digit product format 631870538
Labeler code 63187
Product ID 63187-538_0ac3f14c-c375-408e-a1d7-8412e3420a40
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name valacyclovir hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Proficient Rx LP
Application ANDA201506
Marketing category ANDA
Marketing start 2012-04-05
Substance VALACYCLOVIR HYDROCHLORIDE
Active strength 1 g/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 1 g/1
Harmonized Identifiers# Field, Values table Field Values Unii G447S0T1VC Rxcui 313564
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 63187-538-04 valacyclovir hydrochloride 4 in 1 BOTTLE TABLET, FILM COATED 4 3 63187-538-14 valacyclovir hydrochloride 14 in 1 BOTTLE TABLET, FILM COATED 14 3 63187-538-30 valacyclovir hydrochloride 30 in 1 BOTTLE TABLET, FILM COATED 30 3 63187-538-60 valacyclovir hydrochloride 60 in 1 BOTTLE TABLET, FILM COATED 60 3 63187-538-90 valacyclovir hydrochloride 90 in 1 BOTTLE TABLET, FILM COATED 90 3
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded VALACYCLOVIR HYDROCHLORIDE ACTIVE INGREDIENT G447S0T1VC VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Acyclovir ACTIVE MOIETY X4HES1O11F VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 CELLULOSE, MICROCRYSTALLINE INACTIVE INGREDIENT OP1R32D61U VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 CROSPOVIDONE INACTIVE INGREDIENT 68401960MK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 FD&C BLUE NO. 2 INACTIVE INGREDIENT L06K8R7DQK VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Hypromelloses INACTIVE INGREDIENT 3NXW29V3WO VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 MAGNESIUM STEARATE INACTIVE INGREDIENT 70097M6I30 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 Polyethylene Glycols INACTIVE INGREDIENT 3WJQ0SDW1A VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 63187-538 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PROFICIENT RX LP] 3 Current NDC, Legacy NDC, 5 package rows 20200128_efe37bd1-a236-43cc-828c-b57e8a704d67.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 63187-538-04 63187053804 4 TABLET, FILM COATED in 1 BOTTLE (63187-538-04) 2015-09-01 0000-00-00 No No Current 63187-538-14 63187053814 14 TABLET, FILM COATED in 1 BOTTLE (63187-538-14) 2015-09-01 0000-00-00 No No Current 63187-538-30 63187053830 30 TABLET, FILM COATED in 1 BOTTLE (63187-538-30) 2015-09-01 0000-00-00 No No Current 63187-538-60 63187053860 60 TABLET, FILM COATED in 1 BOTTLE (63187-538-60) 2015-09-01 0000-00-00 No No Current 63187-538-90 63187053890 90 TABLET, FILM COATED in 1 BOTTLE (63187-538-90) 2015-09-01 0000-00-00 No No Current