FDA.reportPublic FDA data

Acyclovir

Product NDC
67296-1543
11-digit product format
672961543
Labeler code
67296
Product ID
67296-1543_d61f9634-7534-4702-e053-2995a90ac0b5
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
RedPharm Drug, Inc.
Application
ANDA075090
Marketing category
ANDA
Marketing start
2015-02-01
Marketing end
0000-00-00
Substance
ACYCLOVIR
Active strength
200 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
67296-1543-12024-08-08C16284748780-11030e365-5d99-111a-e063-dadaa90a10e2acyclovir 200mg
67296-1543-12024-01-30C16284748780-11030e365-5d99-111a-e063-dadaa90a10e2acyclovir 200mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67296-1543-1Acyclovir35 in 1 BOTTLECAPSULE355

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1543ACYCLOVIR CAPSULE [REDPHARM DRUG, INC.]5Legacy NDC, 1 package rows20240809_57eab132-77fc-4282-e053-2a91aa0a2327.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSN57eab132-77fc-4282-e053-2a91aa0a23275
197310acyclovir 200 MG Oral CapsuleSCD57eab132-77fc-4282-e053-2a91aa0a23275
197310acycycloguanosine 200 MG Oral CapsuleSY57eab132-77fc-4282-e053-2a91aa0a23275

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1543-16729615430135 CAPSULE in 1 BOTTLE (67296-1543-1) 35 capsule2015-02-010000-00-00NoNoCurrent