FDA.reportPublic FDA data

Acyclovir

Product NDC
68071-4799
11-digit product format
680714799
Labeler code
68071
Product ID
68071-4799_1adc6334-f5c1-f7cd-e063-6394a90af603
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
ANDA203834
Marketing category
ANDA
Marketing start
2013-11-29
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
68071-4799-52023-12-01C16284748780-1ba0f9c33-1113-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-4799-52023-01-30C16284748780-1ba0f9c33-1113-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-4799-52021-02-17C16284748780-1ba0f9c33-1113-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only
68071-4799-52021-01-29C16284748780-1ba0f9c33-1113-a910-e053-dadaa90a0b85Acyclovir Tablets, USP Rx only

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4799-5Acyclovir25 in 1 BOTTLETABLET254
68071-4799-6Acyclovir60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4799ACYCLOVIR TABLET [NUCARE PHARMACEUTICALS,INC.]4Current NDC, Legacy NDC, 2 package rows20240616_83e82707-85b6-2fea-e053-2991aa0a99ef.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN83e82707-85b6-2fea-e053-2991aa0a99ef4
197311acyclovir 400 MG Oral TabletSCD83e82707-85b6-2fea-e053-2991aa0a99ef4
197311acycycloguanosine 400 MG Oral TabletSY83e82707-85b6-2fea-e053-2991aa0a99ef4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4799-56807147990525 TABLET in 1 BOTTLE (68071-4799-5) 25 tablet2019-03-120000-00-00NoNoCurrent
68071-4799-66807147990660 TABLET in 1 BOTTLE (68071-4799-6) 60 tablet2019-03-12NoNoCurrent