Home NDC 75834-123 Acyclovir
Product NDC 75834-123
11-digit product format 758340123
Labeler code 75834
Product ID 75834-123_d14fe0b4-4772-45ee-b0d9-6ea50e5c9733
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Acyclovir
Dosage form TABLET
Route ORAL
Labeler Nivagen Pharmaceuticals, Inc.
Application ANDA202168
Marketing category ANDA
Marketing start 2016-10-15
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# FDA-Initiated Inactive NDC Indexing# NDC, Effective, Action table NDC Effective Action Document Indexing SPL Related label 75834-123-01 2022-02-15 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2022-02-15 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2022-01-28 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2022-01-28 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2020-05-06 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2020-05-06 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-01 2020-01-31 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc. 75834-123-05 2020-01-31 C162847 48780-1 9d75b9d0-e338-f424-e053-dadaa90a57ce ACYCLOVIR TABLETS, USP Nivagen Pharmaceuticals, Inc.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 75834-123-01 Acyclovir 100 in 1 BOTTLE TABLET 100 4 75834-123-05 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 75834-123 ACYCLOVIR TABLET [NIVAGEN PHARMACEUTICALS, INC.] 4 Current NDC, Legacy NDC, 2 package rows 20220216_7e83897b-9662-4f69-860e-da357800fc55.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 75834-123-01 75834012301 100 TABLET in 1 BOTTLE (75834-123-01) 100 tablet 2016-10-15 0000-00-00 No No Current 75834-123-05 75834012305 500 TABLET in 1 BOTTLE (75834-123-05) 500 tablet 2016-10-15 0000-00-00 No No Current