Acyclovir

Product NDC
53002-0270
11-digit product format
530020270
Labeler code
53002
Product ID
53002-0270_41177fa1-9797-4a34-b620-78eb0edb49f0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RPK Pharmaceuticals, Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
53002-0270-02025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-12025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-22025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-32025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-42025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-52025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-62025-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-02023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-12023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-22023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-32023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-42023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-52023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-62023-06-07C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-02023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-12023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-22023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-32023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-42023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-52023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-62023-01-30C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-02020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-12020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-22020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-32020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-42020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-52020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-62020-12-15C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-02020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-12020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-22020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-32020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-42020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-52020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53002-0270-62020-01-31C16284748780-19d75b9d0-9c16-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53002-0270-0Acyclovir50 in 1 BOTTLETABLET505
53002-0270-1Acyclovir10 in 1 BOTTLETABLET105
53002-0270-2Acyclovir15 in 1 BOTTLETABLET155
53002-0270-3Acyclovir20 in 1 BOTTLETABLET205
53002-0270-4Acyclovir30 in 1 BOTTLETABLET305
53002-0270-5Acyclovir35 in 1 BOTTLETABLET355
53002-0270-6Acyclovir40 in 1 BOTTLETABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53002-0270ACYCLOVIR TABLET [RPK PHARMACEUTICALS, INC.]5Legacy NDC, 7 package rows20230609_b398875e-1150-4a02-a867-6e9853b9ff12.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNb398875e-1150-4a02-a867-6e9853b9ff125
197313acyclovir 800 MG Oral TabletSCDb398875e-1150-4a02-a867-6e9853b9ff125
197313acycycloguanosine 800 MG Oral TabletSYb398875e-1150-4a02-a867-6e9853b9ff125

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53002-0270-05300202700050 TABLET in 1 BOTTLE (53002-0270-0) 50 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-15300202700110 TABLET in 1 BOTTLE (53002-0270-1) 10 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-25300202700215 TABLET in 1 BOTTLE (53002-0270-2) 15 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-35300202700320 TABLET in 1 BOTTLE (53002-0270-3) 20 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-45300202700430 TABLET in 1 BOTTLE (53002-0270-4) 30 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-55300202700535 TABLET in 1 BOTTLE (53002-0270-5) 35 tablet2017-10-010000-00-00NoNoCurrent
53002-0270-65300202700640 TABLET in 1 BOTTLE (53002-0270-6) 40 tablet2017-10-010000-00-00NoNoCurrent