FDA.reportPublic FDA data

Acyclovir

Product NDC
67296-1625
11-digit product format
672961625
Labeler code
67296
Product ID
67296-1625_b8d08b7b-cbf6-9efd-e053-2995a90a89e7
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA202168
Marketing category
ANDA
Marketing start
2019-01-01
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
2022-12-31
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
67296-1625-22023-01-30C16284748780-1f386c64a-2718-0266-e053-dadaa90a7c1aacy 400mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1625-2Acyclovir20 in 1 BOTTLETABLET202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1625ACYCLOVIR TABLET [REDPHARM DRUG, INC.]2Legacy NDC, 1 package rows20210114_888c4158-8b15-aa4f-e053-2a95a90a14fd.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN888c4158-8b15-aa4f-e053-2a95a90a14fd2
197311acyclovir 400 MG Oral TabletSCD888c4158-8b15-aa4f-e053-2a95a90a14fd2
197311acycycloguanosine 400 MG Oral TabletSY888c4158-8b15-aa4f-e053-2a95a90a14fd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1625-26729616250220 TABLET in 1 BOTTLE (67296-1625-2) 20 tablet2019-01-010000-00-00NoNoCurrent