FDA.reportPublic FDA data

Acyclovir

Product NDC
53217-313
11-digit product format
532170313
Labeler code
53217
Product ID
53217-313_5d661e64-29de-488f-8e4d-9b9b0b0a54d7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA075382
Marketing category
ANDA
Marketing start
2017-05-19
Marketing end
0000-00-00
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
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
33190c02-82e1-0a4d-d716-9ccd23588463Product name520250225
c367d1da-5a72-8966-6d11-1eb9a73ae758Product name320231115
5518bf13-db2f-2e9c-3679-e70ecf03752cProduct name920210614
27897900-0e40-497b-97e1-88057e68fe6cProduct name420200710
ca834e59-e669-229c-9288-0ccb76dc373eProduct name920200220
d7f95c49-d3e1-4bbc-a389-e9cd73f59a28Product name120190702
fb15b394-3715-4c87-a447-421489aa8739Product name320170727
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53217-313-502020-01-31C16284748780-19d75b9d0-25c0-f424-e053-dadaa90a57ceAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-313-50Acyclovir50 in 1 BOTTLE, PLASTICTABLET501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-313ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 1 package rows20180522_4eb22254-48d3-4f9d-9db4-0882c05e5763.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN4eb22254-48d3-4f9d-9db4-0882c05e57631
197313acyclovir 800 MG Oral TabletSCD4eb22254-48d3-4f9d-9db4-0882c05e57631
197313acycycloguanosine 800 MG Oral TabletSY4eb22254-48d3-4f9d-9db4-0882c05e57631

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-313-505321703135050 in 1 BOTTLE, PLASTICHistorical