FDA.reportPublic FDA data

Acyclovir

Product NDC
53002-0082
11-digit product format
530020082
Labeler code
53002
Product ID
53002-0082_a52d5ae4-7d93-4390-8d44-c16ab71f38ee
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
Marketing end
0000-00-00
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
2023-12-31
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
53002-0082-12025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-22025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-32025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-42025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-52025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-62025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP
53002-0082-92025-01-30C16284748780-12cef2736-7cc5-d83d-e063-dadaa90ab31fAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0082-1Acyclovir15 in 1 BOTTLETABLET151
53002-0082-2Acyclovir20 in 1 BOTTLETABLET201
53002-0082-3Acyclovir21 in 1 BOTTLETABLET211
53002-0082-4Acyclovir30 in 1 BOTTLETABLET301
53002-0082-5Acyclovir35 in 1 BOTTLETABLET351
53002-0082-6Acyclovir50 in 1 BOTTLETABLET501
53002-0082-9Acyclovir60 in 1 BOTTLETABLET601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0082ACYCLOVIR TABLET [RPK PHARMACEUTICALS, INC.]1Legacy NDC, 7 package rows20220331_6654f203-6465-4089-9c1d-1808b833791a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN6654f203-6465-4089-9c1d-1808b833791a1
197311acyclovir 400 MG Oral TabletSCD6654f203-6465-4089-9c1d-1808b833791a1
197311acycycloguanosine 400 MG Oral TabletSY6654f203-6465-4089-9c1d-1808b833791a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0082-15300200820115 TABLET in 1 BOTTLE (53002-0082-1) 15 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-25300200820220 TABLET in 1 BOTTLE (53002-0082-2) 20 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-35300200820321 TABLET in 1 BOTTLE (53002-0082-3) 21 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-45300200820430 TABLET in 1 BOTTLE (53002-0082-4) 30 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-55300200820535 TABLET in 1 BOTTLE (53002-0082-5) 35 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-65300200820650 TABLET in 1 BOTTLE (53002-0082-6) 50 tablet2021-01-010000-00-00NoNoCurrent
53002-0082-95300200820960 TABLET in 1 BOTTLE (53002-0082-9) 60 tablet2021-01-010000-00-00NoNoCurrent