FDA.reportPublic FDA data

acyclovir

Product NDC
63629-9174
11-digit product format
636299174
Labeler code
63629
Product ID
63629-9174_136ea151-859f-46ad-a6e5-b07f9ea968a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA077309
Marketing category
ANDA
Marketing start
2006-03-13
Marketing end
2026-12-31
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
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
acyclovir

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
63629-9174-1acyclovir50 in 1 BOTTLETABLET50105
63629-9174-2acyclovir60 in 1 BOTTLETABLET60105

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63629-9174-1EA - Each63629-917413d09396-b507-49b2-84b3-efffde4144cf12022-09-12
63629-9174-2EA - Each63629-9174148acf51-accc-46ac-8b3c-430a2740067212022-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63629-9174ACYCLOVIR TABLET [BRYANT RANCH PREPACK]105Current NDC, Legacy NDC, 2 package rows20240602_bf1b4142-c5f3-4147-8224-bf6344566694.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSNbf1b4142-c5f3-4147-8224-bf6344566694105
197313acyclovir 800 MG Oral TabletSCDbf1b4142-c5f3-4147-8224-bf6344566694105
197313acycycloguanosine 800 MG Oral TabletSYbf1b4142-c5f3-4147-8224-bf6344566694105

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63629-9174-16362991740150 TABLET in 1 BOTTLE (63629-9174-1) 50 tablet2022-08-022026-12-31NoNoCurrent
63629-9174-26362991740260 TABLET in 1 BOTTLE (63629-9174-2) 60 tablet2022-08-022026-12-31NoNoCurrent