FDA.reportPublic FDA data

Acyclovir

Product NDC
68788-8203
11-digit product format
687888203
Labeler code
68788
Product ID
68788-8203_67f406ad-9398-4613-a77a-439966f1d0ae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Preferred Pharmaceuticals Inc.
Application
ANDA209366
Marketing category
ANDA
Marketing start
2022-05-26
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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acyclovir
Listing expiration
2027-12-31

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
68788-8203-1Acyclovir100 in 1 BOTTLETABLET1006
68788-8203-2Acyclovir21 in 1 BOTTLETABLET216
68788-8203-3Acyclovir30 in 1 BOTTLETABLET306
68788-8203-4Acyclovir40 in 1 BOTTLETABLET406
68788-8203-5Acyclovir50 in 1 BOTTLETABLET506
68788-8203-8Acyclovir35 in 1 BOTTLETABLET356

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68788-8203-1EA - Each68788-8203b06ee593-5f97-47aa-a659-9211520bc35712022-07-06
68788-8203-2EA - Each68788-82037bd14f5f-f223-4e95-96e7-51fa707416b212022-07-06
68788-8203-3EA - Each68788-820334aa2bb0-dff4-4ab3-9f07-9950111c12ee12022-07-06
68788-8203-4EA - Each68788-82038b554cc8-9075-47c9-9774-23f614948f6f12022-07-06
68788-8203-5EA - Each68788-82035a7b6fd2-4f14-42d8-bb5b-d204de58838412022-07-06
68788-8203-8EA - Each68788-8203d1b9338f-59f0-4ae6-8dba-222fcdd8341012022-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68788-8203ACYCLOVIR TABLET [PREFERRED PHARMACEUTICALS INC.]5Current NDC, Legacy NDC, 6 package rows20250101_b1033fda-8242-4006-b1cd-23474d70671f.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNb1033fda-8242-4006-b1cd-23474d70671f6
197311acyclovir 400 MG Oral TabletSCDb1033fda-8242-4006-b1cd-23474d70671f6
197311acycycloguanosine 400 MG Oral TabletSYb1033fda-8242-4006-b1cd-23474d70671f6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68788-8203-168788820301100 TABLET in 1 BOTTLE (68788-8203-1) 100 tablet2022-05-260000-00-00NoNoCurrent
68788-8203-26878882030221 TABLET in 1 BOTTLE (68788-8203-2) 21 tablet2022-05-260000-00-00NoNoCurrent
68788-8203-36878882030330 TABLET in 1 BOTTLE (68788-8203-3) 30 tablet2022-05-260000-00-00NoNoCurrent
68788-8203-46878882030440 TABLET in 1 BOTTLE (68788-8203-4) 40 tablet2022-05-260000-00-00NoNoCurrent
68788-8203-56878882030550 TABLET in 1 BOTTLE (68788-8203-5) 50 tablet2022-05-260000-00-00NoNoCurrent
68788-8203-86878882030835 TABLET in 1 BOTTLE (68788-8203-8) 35 tablet2022-05-260000-00-00NoNoCurrent