FDA.reportPublic FDA data

acyclovir

Product NDC
63187-192
11-digit product format
631870192
Labeler code
63187
Product ID
63187-192_9c66b198-9eb5-4e9d-89f9-c765eaeb9c69
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Proficient Rx LP
Application
ANDA077309
Marketing category
ANDA
Marketing start
2006-03-13
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
63187-192-30acyclovir30 in 1 BOTTLETABLET304
63187-192-35acyclovir35 in 1 BOTTLETABLET354
63187-192-60acyclovir60 in 1 BOTTLETABLET604
63187-192-90acyclovir90 in 1 BOTTLETABLET904

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [PROFICIENT RX LP]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [PROFICIENT RX LP]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [PROFICIENT RX LP]2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACYCLOVIR TABLET [PROFICIENT RX LP]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [PROFICIENT RX LP]2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ACYCLOVIR TABLET [PROFICIENT RX LP]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63187-192ACYCLOVIR TABLET [PROFICIENT RX LP]4Current NDC, Legacy NDC, 4 package rows20210121_4c5a75fa-73db-4f48-895f-de1635d33f49.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN4c5a75fa-73db-4f48-895f-de1635d33f494
197313acyclovir 800 MG Oral TabletSCD4c5a75fa-73db-4f48-895f-de1635d33f494
197313acycycloguanosine 800 MG Oral TabletSY4c5a75fa-73db-4f48-895f-de1635d33f494

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63187-192-306318701923030 TABLET in 1 BOTTLE (63187-192-30) 30 tablet2019-01-010000-00-00NoNoCurrent
63187-192-356318701923535 TABLET in 1 BOTTLE (63187-192-35) 35 tablet2019-01-010000-00-00NoNoCurrent
63187-192-606318701926060 TABLET in 1 BOTTLE (63187-192-60) 60 tablet2019-01-010000-00-00NoNoCurrent
63187-192-906318701929090 TABLET in 1 BOTTLE (63187-192-90) 90 tablet2019-01-010000-00-00NoNoCurrent