FDA.reportPublic FDA data

Acyclovir

Product NDC
53002-0271
11-digit product format
530020271
Labeler code
53002
Product ID
53002-0271_f794a1d0-e49b-4f3c-8fd2-27e130d6dff0
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
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
2021-12-31
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
53002-0271-02025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-12025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-22025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-32025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-42025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-52025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-62025-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-02023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-12023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-22023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-32023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-42023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-52023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-62023-06-08C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-02023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-12023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-22023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-32023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-42023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-52023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
53002-0271-62023-01-30C16284748780-1f386c649-f46c-0266-e053-dadaa90a7c1aAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0271-0Acyclovir50 in 1 BOTTLETABLET503
53002-0271-1Acyclovir10 in 1 BOTTLETABLET103
53002-0271-2Acyclovir15 in 1 BOTTLETABLET153
53002-0271-3Acyclovir20 in 1 BOTTLETABLET203
53002-0271-4Acyclovir30 in 1 BOTTLETABLET303
53002-0271-5Acyclovir35 in 1 BOTTLETABLET353
53002-0271-6Acyclovir40 in 1 BOTTLETABLET403

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0271ACYCLOVIR TABLET [RPK PHARMACEUTICALS, INC.]3Legacy NDC, 7 package rows20230609_de4858e6-b601-4da2-8af1-2481c2bc6ef6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNde4858e6-b601-4da2-8af1-2481c2bc6ef63
197313acyclovir 800 MG Oral TabletSCDde4858e6-b601-4da2-8af1-2481c2bc6ef63
197313acycycloguanosine 800 MG Oral TabletSYde4858e6-b601-4da2-8af1-2481c2bc6ef63

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0271-05300202710050 TABLET in 1 BOTTLE (53002-0271-0) 50 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-15300202710110 TABLET in 1 BOTTLE (53002-0271-1) 10 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-25300202710215 TABLET in 1 BOTTLE (53002-0271-2) 15 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-35300202710320 TABLET in 1 BOTTLE (53002-0271-3) 20 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-45300202710430 TABLET in 1 BOTTLE (53002-0271-4) 30 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-55300202710535 TABLET in 1 BOTTLE (53002-0271-5) 35 tablet2020-01-010000-00-00NoNoCurrent
53002-0271-65300202710640 TABLET in 1 BOTTLE (53002-0271-6) 40 tablet2020-01-010000-00-00NoNoCurrent