FDA.reportPublic FDA data

Acyclovir

Product NDC
81288-018
11-digit product format
812880018
Labeler code
81288
Product ID
81288-018_d57d68ac-9e19-431d-a086-a055a14ca472
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
EMC PHARMA, LLC
Application
ANDA210401
Marketing category
ANDA
Marketing start
2022-07-29
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
81288-018-012025-01-30C16284748780-12cef2736-76a2-d83d-e063-dadaa90ab31fACYCLOVIR TABLETS, USP 400 mg
81288-018-022025-01-30C16284748780-12cef2736-76a2-d83d-e063-dadaa90ab31fACYCLOVIR TABLETS, USP 400 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81288-018-01Acyclovir100 in 1 BOTTLETABLET1001
81288-018-02Acyclovir500 in 1 BOTTLETABLET5001

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81288-018-01EA - Each81288-018ebde0e31-ea51-4166-b816-3f1877b93b5712022-10-06
81288-018-02EA - Each81288-01815706795-c6f9-4aa1-bed9-a24af2e7c27d12022-10-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81288-018ACYCLOVIR TABLET [EMC PHARMA, LLC]1Legacy NDC, 2 package rows20220729_df3bf969-f339-4abb-9bdd-3525253bc85d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNdf3bf969-f339-4abb-9bdd-3525253bc85d1
197311acyclovir 400 MG Oral TabletSCDdf3bf969-f339-4abb-9bdd-3525253bc85d1
197311acycycloguanosine 400 MG Oral TabletSYdf3bf969-f339-4abb-9bdd-3525253bc85d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
81288-018-0181288001801100 TABLET in 1 BOTTLE (81288-018-01) 100 tablet2022-07-290000-00-00NoNoCurrent
81288-018-0281288001802500 TABLET in 1 BOTTLE (81288-018-02) 500 tablet2022-07-290000-00-00NoNoCurrent