Home NDC 54348-624 Acyclovir
Product NDC 54348-624
11-digit product format 543480624
Labeler code 54348
Product ID 54348-624_ea935f93-6c2c-2e8a-e053-2995a90a2ce0
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name ACYCLOVIR
Dosage form TABLET
Route ORAL
Labeler PharmPak, Inc.
Application ANDA203834
Marketing category ANDA
Marketing start 2019-07-09
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 197313
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54348-624-10 Acyclovir 10 in 1 BOTTLE TABLET 10 2 54348-624-10 Acyclovir 1 in 1 BOX TABLET 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54348-624 ACYCLOVIR TABLET [PHARMPAK, INC.] 2 Current NDC, Legacy NDC, 2 package rows 20221011_d824fc07-9f03-4cb2-9bf8-ff7cc2955255.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 54348-624-10 54348062410 1 BOTTLE in 1 BOX (54348-624-10) / 10 TABLET in 1 BOTTLE 1 bottle 2019-07-09 0000-00-00 No No Current