FDA.reportPublic FDA data

Acyclovir

Product NDC
63629-1678
11-digit product format
636291678
Labeler code
63629
Product ID
63629-1678_493fe3ca-2fb6-43a4-8bfd-44e53804d6f3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA075382
Marketing category
ANDA
Marketing start
2009-10-22
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
63629-1678-0Acyclovir500 in 1 BOTTLETABLET50022
63629-1678-1Acyclovir25 in 1 BOTTLETABLET2522
63629-1678-2Acyclovir35 in 1 BOTTLETABLET3522
63629-1678-3Acyclovir30 in 1 BOTTLETABLET3022
63629-1678-4Acyclovir60 in 1 BOTTLETABLET6022
63629-1678-5Acyclovir50 in 1 BOTTLETABLET5022
63629-1678-6Acyclovir10 in 1 BOTTLETABLET1022
63629-1678-7Acyclovir40 in 1 BOTTLETABLET4022
63629-1678-8Acyclovir21 in 1 BOTTLETABLET2122
63629-1678-9Acyclovir90 in 1 BOTTLETABLET9022

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-1678-1EA - Each63629-16783ed69acc-6e7e-4626-a190-62589f6fae8612012-07-24
63629-1678-2EA - Each63629-1678bf0cda76-c198-4f44-ad18-e10ac8a7c52912012-07-24
63629-1678-3EA - Each63629-16787da81c29-fa81-4e69-98e1-4d123b70c64412012-07-24
63629-1678-4EA - Each63629-1678754681ec-7109-4998-ab6d-9d7addb72cde12012-07-24
63629-1678-5EA - Each63629-167813c0e740-7146-4428-bf9e-e52d408a498c12012-07-24
63629-1678-7EA - Each63629-167850eef86f-78ed-4cd7-a285-a17f5230e61412020-09-14
63629-1678-8EA - Each63629-167894021499-6e61-41cf-8479-7937d5e2d45c12020-09-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACYCLOVIRACTIVE INGREDIENTX4HES1O11FACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
ACYCLOVIRACTIVE MOIETYX4HES1O11FACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I30ACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2ACYCLOVIR TABLET [BRYANT RANCH PREPACK]2
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACYCLOVIR TABLET [BRYANT RANCH PREPACK]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-1678ACYCLOVIR TABLET [BRYANT RANCH PREPACK]22Current NDC, Legacy NDC, 10 package rows20241108_f3cbd634-77c8-3306-bdbd-a4598b20603e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNf3cbd634-77c8-3306-bdbd-a4598b20603e22
197313acyclovir 800 MG Oral TabletSCDf3cbd634-77c8-3306-bdbd-a4598b20603e22
197313acycycloguanosine 800 MG Oral TabletSYf3cbd634-77c8-3306-bdbd-a4598b20603e22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-1678-063629167800500 TABLET in 1 BOTTLE (63629-1678-0) 500 tablet2018-05-210000-00-00NoNoCurrent
63629-1678-16362916780125 TABLET in 1 BOTTLE (63629-1678-1) 25 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-26362916780235 TABLET in 1 BOTTLE (63629-1678-2) 35 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-36362916780330 TABLET in 1 BOTTLE (63629-1678-3) 30 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-46362916780460 TABLET in 1 BOTTLE (63629-1678-4) 60 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-56362916780550 TABLET in 1 BOTTLE (63629-1678-5) 50 tablet2024-10-290000-00-00NoNoCurrent
63629-1678-66362916780610 TABLET in 1 BOTTLE (63629-1678-6) 10 tablet2013-03-280000-00-00NoNoCurrent
63629-1678-76362916780740 TABLET in 1 BOTTLE (63629-1678-7) 40 tablet2011-06-090000-00-00NoNoCurrent
63629-1678-86362916780821 TABLET in 1 BOTTLE (63629-1678-8) 21 tablet2011-11-170000-00-00NoNoCurrent
63629-1678-96362916780990 TABLET in 1 BOTTLE (63629-1678-9) 90 tablet2020-06-040000-00-00NoNoCurrent