Home NDC 69452-291 Acyclovir
Product NDC 69452-291
11-digit product format 694520291
Labeler code 69452
Product ID 69452-291_a0977267-e400-48f6-99fa-dafcc483e96e
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Bionpharma Inc.
Application ANDA209366
Marketing category ANDA
Marketing start 2020-08-15
Substance ACYCLOVIR
Active strength 800 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 800 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 69452-291-20 Acyclovir 100 in 1 BOTTLE TABLET 100 4 69452-291-30 Acyclovir 500 in 1 BOTTLE TABLET 500 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69452-291 ACYCLOVIR TABLET [BIONPHARMA INC.] 4 Current NDC, Legacy NDC, 2 package rows 20231211_6f1db9f0-9b41-4fb7-8798-44fdc2c128df.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 69452-291-20 69452029120 100 TABLET in 1 BOTTLE (69452-291-20) 100 tablet 2020-08-15 0000-00-00 No No Current 69452-291-30 69452029130 500 TABLET in 1 BOTTLE (69452-291-30) 500 tablet 2020-08-15 0000-00-00 No No Current