FDA.reportPublic FDA data

Acyclovir

Product NDC
63187-253
11-digit product format
631870253
Labeler code
63187
Product ID
63187-253_9f75bb4a-0416-403f-92bc-a3d0e50457c6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63187-253-15Acyclovir15 in 1 BOTTLETABLET158
63187-253-21Acyclovir21 in 1 BOTTLETABLET218
63187-253-25Acyclovir25 in 1 BOTTLETABLET258
63187-253-30Acyclovir30 in 1 BOTTLETABLET308
63187-253-60Acyclovir60 in 1 BOTTLETABLET608
63187-253-90Acyclovir90 in 1 BOTTLETABLET908

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-253ACYCLOVIR TABLET [PROFICIENT RX LP]8Current NDC, Legacy NDC, 6 package rows20220413_c55bde35-a202-4c25-b545-e5d5e95c1175.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNc55bde35-a202-4c25-b545-e5d5e95c11758
197311acyclovir 400 MG Oral TabletSCDc55bde35-a202-4c25-b545-e5d5e95c11758
197311acycycloguanosine 400 MG Oral TabletSYc55bde35-a202-4c25-b545-e5d5e95c11758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-253-156318702531515 TABLET in 1 BOTTLE (63187-253-15) 15 tablet2016-10-030000-00-00NoNoCurrent
63187-253-216318702532121 TABLET in 1 BOTTLE (63187-253-21) 21 tablet2015-01-010000-00-00NoNoCurrent
63187-253-256318702532525 TABLET in 1 BOTTLE (63187-253-25) 25 tablet2015-09-010000-00-00NoNoCurrent
63187-253-306318702533030 TABLET in 1 BOTTLE (63187-253-30) 30 tablet2014-11-030000-00-00NoNoCurrent
63187-253-606318702536060 TABLET in 1 BOTTLE (63187-253-60) 60 tablet2014-11-030000-00-00NoNoCurrent
63187-253-906318702539090 TABLET in 1 BOTTLE (63187-253-90) 90 tablet2014-11-030000-00-00NoNoCurrent