FDA.reportPublic FDA data

Acyclovir

Product NDC
69117-0019
11-digit product format
691170019
Labeler code
69117
Product ID
69117-0019_4727ec9e-f954-a44e-e063-6394a90a2c04
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
YILING PHARMACEUTICAL, INC.
Application
ANDA210401
Marketing category
ANDA
Marketing start
2018-05-04
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
69117-0019-1Acyclovir100 in 1 BOTTLETABLET1006
69117-0019-2Acyclovir500 in 1 BOTTLETABLET5006

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0019-1EA - Each69117-0019df9ed45f-6070-455c-aa96-c825a973234112018-09-05
69117-0019-2EA - Each69117-001969ac961d-b9af-4fe3-a410-c7d4e674013f12018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0019ACYCLOVIR TABLET [YILING PHARMACEUTICAL, INC.]5Current NDC, Legacy NDC, 2 package rows20250101_67e7b340-0635-2595-e053-2a91aa0ad266.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197313acyclovir 800 MG Oral TabletPSN67e7b340-0635-2595-e053-2a91aa0ad2666
197313acyclovir 800 MG Oral TabletPSN8d171c3d-de39-4f82-bacb-3e8d71b165406
197313acyclovir 800 MG Oral TabletSCD67e7b340-0635-2595-e053-2a91aa0ad2666
197313acyclovir 800 MG Oral TabletSCD8d171c3d-de39-4f82-bacb-3e8d71b165406
197313acycycloguanosine 800 MG Oral TabletSY67e7b340-0635-2595-e053-2a91aa0ad2666
197313acycycloguanosine 800 MG Oral TabletSY8d171c3d-de39-4f82-bacb-3e8d71b165406
197313acyclovir 800 MG Oral TabletPSNf3bd98ba-968d-7003-e053-2a95a90a7ecb2
197313acyclovir 800 MG Oral TabletSCDf3bd98ba-968d-7003-e053-2a95a90a7ecb2
197313acycycloguanosine 800 MG Oral TabletSYf3bd98ba-968d-7003-e053-2a95a90a7ecb2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0019-169117001901100 TABLET in 1 BOTTLE (69117-0019-1) 100 tablet2018-05-040000-00-00NoNoCurrent
69117-0019-269117001902500 TABLET in 1 BOTTLE (69117-0019-2) 500 tablet2018-05-040000-00-00NoNoCurrent