FDA.reportPublic FDA data

Acyclovir

Product NDC
63187-574
11-digit product format
631870574
Labeler code
63187
Product ID
63187-574_4a7f6547-dac8-4cf9-9834-ae6815f154b5
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
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
63187-574-06Acyclovir06 in 1 BOTTLETABLET066
63187-574-20Acyclovir20 in 1 BOTTLETABLET206
63187-574-25Acyclovir25 in 1 BOTTLETABLET256
63187-574-30Acyclovir30 in 1 BOTTLETABLET306
63187-574-35Acyclovir35 in 1 BOTTLETABLET356
63187-574-50Acyclovir50 in 1 BOTTLETABLET506
63187-574-60Acyclovir60 in 1 BOTTLETABLET606
63187-574-90Acyclovir90 in 1 BOTTLETABLET906

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-574ACYCLOVIR TABLET [PROFICIENT RX LP]6Current NDC, Legacy NDC, 8 package rows20220626_9e5b3a11-9c4b-4998-8a18-3046af1314ab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN9e5b3a11-9c4b-4998-8a18-3046af1314ab6
197313acyclovir 800 MG Oral TabletSCD9e5b3a11-9c4b-4998-8a18-3046af1314ab6
197313acycycloguanosine 800 MG Oral TabletSY9e5b3a11-9c4b-4998-8a18-3046af1314ab6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-574-06631870574066 TABLET in 1 BOTTLE (63187-574-06) 6 tablet2018-09-040000-00-00NoNoCurrent
63187-574-206318705742020 TABLET in 1 BOTTLE (63187-574-20) 20 tablet2015-02-020000-00-00NoNoCurrent
63187-574-256318705742525 TABLET in 1 BOTTLE (63187-574-25) 25 tablet2019-02-010000-00-00NoNoCurrent
63187-574-306318705743030 TABLET in 1 BOTTLE (63187-574-30) 30 tablet2015-02-020000-00-00NoNoCurrent
63187-574-356318705743535 TABLET in 1 BOTTLE (63187-574-35) 35 tablet2015-02-020000-00-00NoNoCurrent
63187-574-506318705745050 TABLET in 1 BOTTLE (63187-574-50) 50 tablet2015-02-020000-00-00NoNoCurrent
63187-574-606318705746060 TABLET in 1 BOTTLE (63187-574-60) 60 tablet2015-02-020000-00-00NoNoCurrent
63187-574-906318705749090 TABLET in 1 BOTTLE (63187-574-90) 90 tablet2015-02-020000-00-00NoNoCurrent