FDA.reportPublic FDA data

acyclovir

Product NDC
63187-366
11-digit product format
631870366
Labeler code
63187
Product ID
63187-366_0f60482e-7e09-458c-9854-ea4578a08c4a
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA204314
Marketing category
ANDA
Marketing start
2014-09-10
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
63187-366-30acyclovir30 in 1 BOTTLETABLET303
63187-366-35acyclovir35 in 1 BOTTLETABLET353
63187-366-60acyclovir60 in 1 BOTTLETABLET603
63187-366-90acyclovir90 in 1 BOTTLETABLET903

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-366ACYCLOVIR TABLET [PROFICIENT RX LP]3Current NDC, Legacy NDC, 4 package rows20210115_3da54b2d-a206-4ff5-8cc2-90762c4fd70d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN3da54b2d-a206-4ff5-8cc2-90762c4fd70d3
197313acyclovir 800 MG Oral TabletSCD3da54b2d-a206-4ff5-8cc2-90762c4fd70d3
197313acycycloguanosine 800 MG Oral TabletSY3da54b2d-a206-4ff5-8cc2-90762c4fd70d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-366-306318703663030 TABLET in 1 BOTTLE (63187-366-30) 30 tablet2016-08-180000-00-00NoNoCurrent
63187-366-356318703663535 TABLET in 1 BOTTLE (63187-366-35) 35 tablet2016-08-180000-00-00NoNoCurrent
63187-366-606318703666060 TABLET in 1 BOTTLE (63187-366-60) 60 tablet2016-08-180000-00-00NoNoCurrent
63187-366-906318703669090 TABLET in 1 BOTTLE (63187-366-90) 90 tablet2016-08-180000-00-00NoNoCurrent