FDA.reportPublic FDA data

Acyclovir

Product NDC
69117-0018
11-digit product format
691170018
Labeler code
69117
Product ID
69117-0018_47285cec-4cb5-07cc-e063-6294a90af06a
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
400 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
ACYCLOVIR400 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197311

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
69117-0018-1Acyclovir100 in 1 BOTTLETABLET1009
69117-0018-2Acyclovir500 in 1 BOTTLETABLET5009

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69117-0018-1EA - Each69117-00186e50aa43-459d-4c85-b38b-71f8aadadd3612018-09-05
69117-0018-2EA - Each69117-0018a8aa51bf-b186-4f0d-833f-47393834f59612018-09-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69117-0018ACYCLOVIR TABLET [YILING PHARMACEUTICAL, INC.]8Current NDC, Legacy NDC, 2 package rows20250101_677edfd5-2d04-b932-e053-2a91aa0a26b0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN677edfd5-2d04-b932-e053-2a91aa0a26b09
197311acyclovir 400 MG Oral TabletSCD677edfd5-2d04-b932-e053-2a91aa0a26b09
197311acycycloguanosine 400 MG Oral TabletSY677edfd5-2d04-b932-e053-2a91aa0a26b09
197311acyclovir 400 MG Oral TabletPSN290af212-7332-4914-9ef0-65760478fb323
197311acyclovir 400 MG Oral TabletSCD290af212-7332-4914-9ef0-65760478fb323
197311acycycloguanosine 400 MG Oral TabletSY290af212-7332-4914-9ef0-65760478fb323
197311acyclovir 400 MG Oral TabletPSNb28714cf-dfbf-404b-92d5-3c25437d98b61
197311acyclovir 400 MG Oral TabletSCDb28714cf-dfbf-404b-92d5-3c25437d98b61
197311acycycloguanosine 400 MG Oral TabletSYb28714cf-dfbf-404b-92d5-3c25437d98b61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69117-0018-169117001801100 TABLET in 1 BOTTLE (69117-0018-1) 100 tablet2018-05-040000-00-00NoNoCurrent
69117-0018-269117001802500 TABLET in 1 BOTTLE (69117-0018-2) 500 tablet2018-05-040000-00-00NoNoCurrent