FDA.reportPublic FDA data

Acyclovir

Product NDC
82804-012
11-digit product format
828040012
Labeler code
82804
Product ID
82804-012_14b524cc-8610-480d-8ce1-ab11f2a9f4d0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
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
Rxcui197313

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82804-012-30Acyclovir30 in 1 BOTTLETABLET303
82804-012-35Acyclovir35 in 1 BOTTLETABLET353
82804-012-50Acyclovir50 in 1 BOTTLETABLET503
82804-012-60Acyclovir60 in 1 BOTTLETABLET603
82804-012-90Acyclovir90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82804-012ACYCLOVIR TABLET [PROFICIENT RX LP]2Current NDC, 5 package rows20231118_d0908b3c-f5dd-4113-9080-bb01abe13c9c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNd0908b3c-f5dd-4113-9080-bb01abe13c9c3
197313acyclovir 800 MG Oral TabletSCDd0908b3c-f5dd-4113-9080-bb01abe13c9c3
197313acycycloguanosine 800 MG Oral TabletSYd0908b3c-f5dd-4113-9080-bb01abe13c9c3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82804-012-308280400123030 TABLET in 1 BOTTLE (82804-012-30) 30 tablet2023-09-21NoNoCurrent
82804-012-358280400123535 TABLET in 1 BOTTLE (82804-012-35) 35 tablet2023-11-16NoNoCurrent
82804-012-508280400125050 TABLET in 1 BOTTLE (82804-012-50) 50 tablet2025-07-09NoNoCurrent
82804-012-608280400126060 TABLET in 1 BOTTLE (82804-012-60) 60 tablet2023-09-21NoNoCurrent
82804-012-908280400129090 TABLET in 1 BOTTLE (82804-012-90) 90 tablet2023-09-21NoNoCurrent