FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-9620
11-digit product format
713359620
Labeler code
71335
Product ID
71335-9620_57a5f652-a53e-4092-b597-28ef1bb60f17
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA209366
Marketing category
ANDA
Marketing start
2020-08-15
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
71335-9620-0Acyclovir120 in 1 BOTTLETABLET120103
71335-9620-1Acyclovir20 in 1 BOTTLETABLET20103
71335-9620-2Acyclovir28 in 1 BOTTLETABLET28103
71335-9620-3Acyclovir30 in 1 BOTTLETABLET30103
71335-9620-4Acyclovir50 in 1 BOTTLETABLET50103
71335-9620-5Acyclovir15 in 1 BOTTLETABLET15103
71335-9620-6Acyclovir60 in 1 BOTTLETABLET60103
71335-9620-7Acyclovir25 in 1 BOTTLETABLET25103
71335-9620-8Acyclovir10 in 1 BOTTLETABLET10103
71335-9620-9Acyclovir40 in 1 BOTTLETABLET40103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-9620ACYCLOVIR TABLET [BRYANT RANCH PREPACK]102Current NDC, Legacy NDC, 10 package rows20240412_e73ae5c8-7a77-4330-817d-482d1de4e994.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acyclovir 400 MG Oral TabletSCDe73ae5c8-7a77-4330-817d-482d1de4e994103
197311acycycloguanosine 400 MG Oral TabletSYe73ae5c8-7a77-4330-817d-482d1de4e994103

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71335-9620-071335962000120 TABLET in 1 BOTTLE (71335-9620-0) 120 tablet2024-04-050000-00-00NoNoCurrent
71335-9620-17133596200120 TABLET in 1 BOTTLE (71335-9620-1) 20 tablet2023-03-270000-00-00NoNoCurrent
71335-9620-27133596200228 TABLET in 1 BOTTLE (71335-9620-2) 28 tablet2024-04-050000-00-00NoNoCurrent
71335-9620-37133596200330 TABLET in 1 BOTTLE (71335-9620-3) 30 tablet2024-04-050000-00-00NoNoCurrent
71335-9620-47133596200450 TABLET in 1 BOTTLE (71335-9620-4) 50 tablet2024-04-050000-00-00NoNoCurrent
71335-9620-57133596200515 TABLET in 1 BOTTLE (71335-9620-5) 15 tablet2023-03-210000-00-00NoNoCurrent
71335-9620-67133596200660 TABLET in 1 BOTTLE (71335-9620-6) 60 tablet2023-04-190000-00-00NoNoCurrent
71335-9620-77133596200725 TABLET in 1 BOTTLE (71335-9620-7) 25 tablet2023-01-030000-00-00NoNoCurrent
71335-9620-87133596200810 TABLET in 1 BOTTLE (71335-9620-8) 10 tablet2024-04-050000-00-00NoNoCurrent
71335-9620-97133596200940 TABLET in 1 BOTTLE (71335-9620-9) 40 tablet2024-04-050000-00-00NoNoCurrent