FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-2447
11-digit product format
680712447
Labeler code
68071
Product ID
68071-2447_2048c55f-8391-e891-e063-6394a90a06fb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
68071-2447-12024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-32024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-42024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-52024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-62024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-82024-08-22C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-12023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-32023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-42023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-52023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-62023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP
68071-2447-82023-01-30C16284748780-1f386c649-9c64-0266-e053-dadaa90a7c1aAcyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-2447-1Acyclovir21 in 1 BOTTLE, PLASTICTABLET212
68071-2447-3Acyclovir30 in 1 BOTTLE, PLASTICTABLET302
68071-2447-4Acyclovir40 in 1 BOTTLE, PLASTICTABLET402
68071-2447-5Acyclovir25 in 1 BOTTLE, PLASTICTABLET252
68071-2447-6Acyclovir60 in 1 BOTTLE, PLASTICTABLET602
68071-2447-8Acyclovir15 in 1 BOTTLE, PLASTICTABLET152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-2447ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC, 6 package rows20240823_c46d5033-b1b2-e213-e053-2995a90ae6a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc46d5033-b1b2-e213-e053-2995a90ae6a32
197311acyclovir 400 MG Oral TabletSCDc46d5033-b1b2-e213-e053-2995a90ae6a32
197311acycycloguanosine 400 MG Oral TabletSYc46d5033-b1b2-e213-e053-2995a90ae6a32

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-2447-16807124470121 TABLET in 1 BOTTLE, PLASTIC (68071-2447-1) 21 tablet2021-06-100000-00-00NoNoCurrent
68071-2447-36807124470330 TABLET in 1 BOTTLE, PLASTIC (68071-2447-3) 30 tablet2021-06-100000-00-00NoNoCurrent
68071-2447-46807124470440 TABLET in 1 BOTTLE, PLASTIC (68071-2447-4) 40 tablet2021-06-100000-00-00NoNoCurrent
68071-2447-56807124470525 TABLET in 1 BOTTLE, PLASTIC (68071-2447-5) 25 tablet2021-06-100000-00-00NoNoCurrent
68071-2447-66807124470660 TABLET in 1 BOTTLE, PLASTIC (68071-2447-6) 60 tablet2021-06-100000-00-00NoNoCurrent
68071-2447-86807124470815 TABLET in 1 BOTTLE, PLASTIC (68071-2447-8) 15 tablet2021-06-100000-00-00NoNoCurrent