FDA.reportPublic FDA data

acyclovir

Product NDC
50090-3795
11-digit product format
500903795
Labeler code
50090
Product ID
50090-3795_e63ff3bd-1eb7-4884-849e-2b1338e2fb80
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
2022-12-31
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
50090-3795-02023-01-30C16284748780-1f386c649-f281-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3795-22023-01-30C16284748780-1f386c649-f281-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only
50090-3795-32023-01-30C16284748780-1f386c649-f281-0266-e053-dadaa90a7c1aAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-3795-0acyclovir35 in 1 BOTTLETABLET357
50090-3795-2acyclovir70 in 1 BOTTLE, PLASTICTABLET707
50090-3795-3acyclovir40 in 1 BOTTLETABLET407

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-3795ACYCLOVIR TABLET [A-S MEDICATION SOLUTIONS]7Legacy NDC, 3 package rows20210417_d2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7
197313acyclovir 800 MG Oral TabletSCDd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7
197313acycycloguanosine 800 MG Oral TabletSYd2a287f7-98c4-4a34-ad4c-e8a5dccc8a3f7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-3795-05009037950035 TABLET in 1 BOTTLE (50090-3795-0) 35 tablet2018-11-080000-00-00NoNoCurrent
50090-3795-25009037950270 TABLET in 1 BOTTLE, PLASTIC (50090-3795-2) 70 tablet2014-11-280000-00-00NoNoCurrent
50090-3795-35009037950340 TABLET in 1 BOTTLE (50090-3795-3) 40 tablet2018-11-080000-00-00NoNoCurrent