FDA.reportPublic FDA data

acyclovir

Product NDC
50436-0792
11-digit product format
504360792
Labeler code
50436
Product ID
50436-0792_60be9ae1-1026-4c6b-a942-3f675341e9b6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Unit Dose Services
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
2020-12-31
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
50436-0792-12021-01-29C16284748780-1ba0f9c33-17e4-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50436-0792-1acyclovir35 in 1 BOTTLETABLET351

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50436-0792ACYCLOVIR TABLET [UNIT DOSE SERVICES]1Legacy NDC, 1 package rows20160803_3f6d9728-5f8c-4a6f-8295-612f39f76fdb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN3f6d9728-5f8c-4a6f-8295-612f39f76fdb1
197313acyclovir 800 MG Oral TabletSCD3f6d9728-5f8c-4a6f-8295-612f39f76fdb1
197313acycycloguanosine 800 MG Oral TabletSY3f6d9728-5f8c-4a6f-8295-612f39f76fdb1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
50436-0792-15043607920135 in 1 BOTTLEHistorical