FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
71335-1645
11-digit product format
713351645
Labeler code
71335
Product ID
71335-1645_66494894-8469-4633-ba3e-2b02aa2aa4eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA074891
Marketing category
ANDA
Marketing start
2013-08-08
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
71335-1645-0ACYCLOVIR120 in 1 BOTTLETABLET1206
71335-1645-1ACYCLOVIR20 in 1 BOTTLETABLET206
71335-1645-2ACYCLOVIR28 in 1 BOTTLETABLET286
71335-1645-3ACYCLOVIR30 in 1 BOTTLETABLET306
71335-1645-4ACYCLOVIR50 in 1 BOTTLETABLET506
71335-1645-5ACYCLOVIR15 in 1 BOTTLETABLET156
71335-1645-6ACYCLOVIR60 in 1 BOTTLETABLET606
71335-1645-7ACYCLOVIR25 in 1 BOTTLETABLET256
71335-1645-8ACYCLOVIR10 in 1 BOTTLETABLET106
71335-1645-9ACYCLOVIR40 in 1 BOTTLETABLET406

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1645ACYCLOVIR TABLET [BRYANT RANCH PREPACK]6Current NDC, Legacy NDC, 10 package rows20240526_331fe0bd-6bb2-4337-8faa-d0c82ff54dc7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN331fe0bd-6bb2-4337-8faa-d0c82ff54dc76
197311acyclovir 400 MG Oral TabletSCD331fe0bd-6bb2-4337-8faa-d0c82ff54dc76
197311acycycloguanosine 400 MG Oral TabletSY331fe0bd-6bb2-4337-8faa-d0c82ff54dc76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-1645-071335164500120 TABLET in 1 BOTTLE (71335-1645-0) 120 tablet2020-07-090000-00-00NoNoCurrent
71335-1645-17133516450120 TABLET in 1 BOTTLE (71335-1645-1) 20 tablet2020-07-020000-00-00NoNoCurrent
71335-1645-27133516450228 TABLET in 1 BOTTLE (71335-1645-2) 28 tablet2022-01-280000-00-00NoNoCurrent
71335-1645-37133516450330 TABLET in 1 BOTTLE (71335-1645-3) 30 tablet2020-06-250000-00-00NoNoCurrent
71335-1645-47133516450450 TABLET in 1 BOTTLE (71335-1645-4) 50 tablet2022-01-280000-00-00NoNoCurrent
71335-1645-57133516450515 TABLET in 1 BOTTLE (71335-1645-5) 15 tablet2022-01-280000-00-00NoNoCurrent
71335-1645-67133516450660 TABLET in 1 BOTTLE (71335-1645-6) 60 tablet2020-09-230000-00-00NoNoCurrent
71335-1645-77133516450725 TABLET in 1 BOTTLE (71335-1645-7) 25 tablet2020-12-180000-00-00NoNoCurrent
71335-1645-87133516450810 TABLET in 1 BOTTLE (71335-1645-8) 10 tablet2020-12-230000-00-00NoNoCurrent
71335-1645-97133516450940 TABLET in 1 BOTTLE (71335-1645-9) 40 tablet2022-01-280000-00-00NoNoCurrent