Home NDC 72789-264 Valacyclovir Hydrochloride
Product NDC 72789-264
11-digit product format 727890264
Labeler code 72789
Product ID 72789-264_4bace65f-2eb6-8f0f-e063-6394a90a0b11
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Valacyclovir Hydrochloride
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PD-Rx Pharmaceuticals, Inc.
Application ANDA090682
Marketing category ANDA
Marketing start 2010-05-24
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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Valacyclovir Hydrochloride
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength VALACYCLOVIR HYDROCHLORIDE 500 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii G447S0T1VC Rxcui 313565
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 72789-264-30 Valacyclovir Hydrochloride 30 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 30 20
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72789-264 VALACYCLOVIR HYDROCHLORIDE TABLET, FILM COATED [PD-RX PHARMACEUTICALS, INC.] 18 Current NDC, Legacy NDC, 1 package rows 20240426_e300970d-1145-4460-a8c8-f6e1654c2c3d.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 72789-264-30 72789026430 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (72789-264-30) 2022-07-22 0000-00-00 No No Current