FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-1053
11-digit product format
713351053
Labeler code
71335
Product ID
71335-1053_93537a74-6bc3-4da2-865f-73752bf24e54
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
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
71335-1053-0Acyclovir120 in 1 BOTTLETABLET1208
71335-1053-1Acyclovir20 in 1 BOTTLETABLET208
71335-1053-2Acyclovir28 in 1 BOTTLETABLET288
71335-1053-3Acyclovir30 in 1 BOTTLETABLET308
71335-1053-4Acyclovir50 in 1 BOTTLETABLET508
71335-1053-5Acyclovir15 in 1 BOTTLETABLET158
71335-1053-6Acyclovir60 in 1 BOTTLETABLET608
71335-1053-7Acyclovir25 in 1 BOTTLETABLET258
71335-1053-8Acyclovir10 in 1 BOTTLETABLET108
71335-1053-9Acyclovir40 in 1 BOTTLETABLET408

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-1053-0EA - Each71335-105349696220-b55c-408b-9fd0-25b7df63c65212020-09-14
71335-1053-1EA - Each71335-1053f58c2bd3-8f91-4055-8890-ca125dd3a24612020-09-14
71335-1053-2EA - Each71335-105349b19d5c-106d-4ca2-b915-bdacb5dd1d3012020-09-14
71335-1053-3EA - Each71335-10531553f3d8-73aa-48aa-9221-e9bb0a08b67b12020-09-14
71335-1053-4EA - Each71335-10538710c334-7b2b-4ba4-9a13-b9661a33b78b12020-09-14
71335-1053-6EA - Each71335-1053cbc1a761-4526-4d05-8569-5af6773a644f12020-09-14
71335-1053-8EA - Each71335-1053479ea726-b56c-49dd-93dc-053f654cfdc712020-09-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1053ACYCLOVIR TABLET [BRYANT RANCH PREPACK]8Current NDC, Legacy NDC, 10 package rows20240913_89583890-186b-4a7a-8741-41f6c5f0a99d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN89583890-186b-4a7a-8741-41f6c5f0a99d8
197311acyclovir 400 MG Oral TabletSCD89583890-186b-4a7a-8741-41f6c5f0a99d8
197311acycycloguanosine 400 MG Oral TabletSY89583890-186b-4a7a-8741-41f6c5f0a99d8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1053-071335105300120 TABLET in 1 BOTTLE (71335-1053-0) 120 tablet2019-11-130000-00-00NoNoCurrent
71335-1053-17133510530120 TABLET in 1 BOTTLE (71335-1053-1) 20 tablet2019-02-190000-00-00NoNoCurrent
71335-1053-27133510530228 TABLET in 1 BOTTLE (71335-1053-2) 28 tablet2020-02-060000-00-00NoNoCurrent
71335-1053-37133510530330 TABLET in 1 BOTTLE (71335-1053-3) 30 tablet2019-01-280000-00-00NoNoCurrent
71335-1053-47133510530450 TABLET in 1 BOTTLE (71335-1053-4) 50 tablet2019-01-150000-00-00NoNoCurrent
71335-1053-57133510530515 TABLET in 1 BOTTLE (71335-1053-5) 15 tablet2020-06-010000-00-00NoNoCurrent
71335-1053-67133510530660 TABLET in 1 BOTTLE (71335-1053-6) 60 tablet2019-01-080000-00-00NoNoCurrent
71335-1053-77133510530725 TABLET in 1 BOTTLE (71335-1053-7) 25 tablet2021-03-020000-00-00NoNoCurrent
71335-1053-87133510530810 TABLET in 1 BOTTLE (71335-1053-8) 10 tablet2020-01-030000-00-00NoNoCurrent
71335-1053-97133510530940 TABLET in 1 BOTTLE (71335-1053-9) 40 tablet2022-08-240000-00-00NoNoCurrent