FDA.reportPublic FDA data

acyclovir

Product NDC
53217-188
11-digit product format
532170188
Labeler code
53217
Product ID
53217-188_6d774336-edd3-4d24-b05c-6a54f44016d3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Aidarex Pharmaceuticals LLC
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
2019-12-31
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
53217-188-152020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53217-188-212020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53217-188-252020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53217-188-302020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53217-188-502020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only
53217-188-602020-01-31C16284748780-19d75b9d0-d960-f424-e053-dadaa90a57ceAcyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53217-188-15acyclovir15 in 1 BOTTLETABLET151
53217-188-21acyclovir21 in 1 BOTTLETABLET211
53217-188-25acyclovir25 in 1 BOTTLETABLET251
53217-188-30acyclovir30 in 1 BOTTLETABLET301
53217-188-50acyclovir50 in 1 BOTTLETABLET501
53217-188-60acyclovir60 in 1 BOTTLETABLET601

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53217-188-15EA - Each53217-18850f28cf7-b9f0-48e3-9bdb-81c5d918ffa012017-03-06
53217-188-21EA - Each53217-18815e56226-436a-47ac-be2c-b3aed43afe8912017-03-06
53217-188-25EA - Each53217-188a5e81261-7147-4161-bc42-af716e85f09312017-03-06
53217-188-30EA - Each53217-188f550b53b-764c-49a7-a34b-a9303be030b712017-03-06
53217-188-50EA - Each53217-1888ce9f1d9-1f15-4fa6-bbf4-25b5799e374012017-03-06
53217-188-60EA - Each53217-188b748ed1b-4b27-409a-91bb-5f932b7d5ec812017-03-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53217-188ACYCLOVIR TABLET [AIDAREX PHARMACEUTICALS LLC]1Legacy NDC, 6 package rows20170225_3399cc2e-8596-450d-91df-434dac0aab85.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN3399cc2e-8596-450d-91df-434dac0aab851
197311acyclovir 400 MG Oral TabletSCD3399cc2e-8596-450d-91df-434dac0aab851
197311acycycloguanosine 400 MG Oral TabletSY3399cc2e-8596-450d-91df-434dac0aab851

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
53217-188-155321701881515 in 1 BOTTLEHistorical
53217-188-215321701882121 in 1 BOTTLEHistorical
53217-188-255321701882525 in 1 BOTTLEHistorical
53217-188-305321701883030 in 1 BOTTLEHistorical
53217-188-505321701885050 in 1 BOTTLEHistorical
53217-188-605321701886060 in 1 BOTTLEHistorical