Home NDC 69367-137 Acyclovir
Product NDC 69367-137
11-digit product format 693670137
Labeler code 69367
Product ID 69367-137_629d8ddb-bba0-4dd8-8621-1bd2a7b129dc
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Westminster Pharmaceuticals, LLC
Application ANDA210401
Marketing category ANDA
Marketing start 2023-06-20
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 2027-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Acyclovir
Listing expiration 2027-12-31 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 69367-137-01 Acyclovir 100 in 1 BOTTLE TABLET 100 5 69367-137-05 Acyclovir 500 in 1 BOTTLE TABLET 500 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69367-137 ACYCLOVIR TABLET [WESTMINSTER PHARMACEUTICALS, LLC] 2 Current NDC, 2 package rows 20230629_f352a641-988e-4878-8016-2b69cd6ee548.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69367-137-01 69367013701 100 TABLET in 1 BOTTLE (69367-137-01) 100 tablet 2023-06-20 No No Current 69367-137-05 69367013705 500 TABLET in 1 BOTTLE (69367-137-05) 500 tablet 2023-06-20 No No Current