Home NDC 59651-965 ACYCLOVIR
Product NDC 59651-965
11-digit product format 596510965
Labeler code 59651
Product ID 59651-965_41cc963e-4d7b-49bd-b281-d5aaa9133026
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACYCLOVIR
Dosage form TABLET
Route ORAL
Labeler Aurobindo Pharma Limited
Application ANDA075211
Marketing category ANDA
Marketing start 2025-09-11
Substance ACYCLOVIR
Active strength 400 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 ACYCLOVIR
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACYCLOVIR 400 mg/1
Harmonized Identifiers# Field, Values table Field Values Unii X4HES1O11F Rxcui 197311, 197313
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 59651-965-01 ACYCLOVIR 100 in 1 BOTTLE TABLET 100 2 59651-965-05 ACYCLOVIR 500 in 1 BOTTLE TABLET 500 2 59651-965-10 ACYCLOVIR 10 in 1 BOTTLE TABLET 10 2
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 59651-965-01 59651096501 100 TABLET in 1 BOTTLE (59651-965-01) 100 tablet 2025-09-11 No No Historical 59651-965-05 59651096505 500 TABLET in 1 BOTTLE (59651-965-05) 500 tablet 2025-09-11 No No Historical 59651-965-10 59651096510 10 TABLET in 1 BOTTLE (59651-965-10) 10 tablet 2025-09-11 No No Historical