FDA.reportPublic FDA data

Acyclovir

Product NDC
76483-042
11-digit product format
764830042
Labeler code
76483
Product ID
76483-042_2b705cc7-7286-4acb-a3e7-95c65fc90bc3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
SQUARE PHARMACEUTICALS LIMITED
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-01-31
Substance
ACYCLOVIR
Active strength
800 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
ACYCLOVIR800 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311, 197313

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
76483-042-002023-07-03C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP
76483-042-042023-07-03C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP
76483-042-052023-07-03C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP
76483-042-002022-01-28C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP
76483-042-042022-01-28C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP
76483-042-052022-01-28C16284748780-1d6a99b39-5098-a426-e053-dadaa90af4c2Acyclovir Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76483-042-00Acyclovir30 in 1 BOTTLETABLET305
76483-042-04Acyclovir100 in 1 BOTTLETABLET1005
76483-042-05Acyclovir500 in 1 BOTTLETABLET5005

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76483-042ACYCLOVIR TABLET [SQUARE PHARMACEUTICALS LIMITED]5Current NDC, Legacy NDC, 3 package rows20230706_b24201ea-aeae-4de1-b01b-eee89068e786.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNb24201ea-aeae-4de1-b01b-eee89068e7865
197313acyclovir 800 MG Oral TabletPSNb24201ea-aeae-4de1-b01b-eee89068e7865
197311acyclovir 400 MG Oral TabletSCDb24201ea-aeae-4de1-b01b-eee89068e7865
197313acyclovir 800 MG Oral TabletSCDb24201ea-aeae-4de1-b01b-eee89068e7865
197311acycycloguanosine 400 MG Oral TabletSYb24201ea-aeae-4de1-b01b-eee89068e7865
197313acycycloguanosine 800 MG Oral TabletSYb24201ea-aeae-4de1-b01b-eee89068e7865

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
76483-042-007648300420030 TABLET in 1 BOTTLE (76483-042-00) 30 tablet2020-01-310000-00-00NoNoCurrent
76483-042-0476483004204100 TABLET in 1 BOTTLE (76483-042-04) 100 tablet2020-01-310000-00-00NoNoCurrent
76483-042-0576483004205500 TABLET in 1 BOTTLE (76483-042-05) 500 tablet2020-01-310000-00-00NoNoCurrent