FDA.reportPublic FDA data

Acyclovir

Product NDC
71335-3103
11-digit product format
713353103
Labeler code
71335
Product ID
71335-3103_465aaa54-8e0b-4a0e-9ea0-7f01ba2a6152
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA210401
Marketing category
ANDA
Marketing start
2023-06-20
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
71335-3103-0Acyclovir120 in 1 BOTTLETABLET1201
71335-3103-1Acyclovir20 in 1 BOTTLETABLET201
71335-3103-2Acyclovir28 in 1 BOTTLETABLET281
71335-3103-3Acyclovir30 in 1 BOTTLETABLET301
71335-3103-4Acyclovir50 in 1 BOTTLETABLET501
71335-3103-5Acyclovir15 in 1 BOTTLETABLET151
71335-3103-6Acyclovir60 in 1 BOTTLETABLET601
71335-3103-7Acyclovir25 in 1 BOTTLETABLET251
71335-3103-8Acyclovir10 in 1 BOTTLETABLET101
71335-3103-9Acyclovir40 in 1 BOTTLETABLET401

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSN69e5455e-d0be-4c2b-b9ab-458b5480ed571
197311acyclovir 400 MG Oral TabletSCD69e5455e-d0be-4c2b-b9ab-458b5480ed571
197311acycycloguanosine 400 MG Oral TabletSY69e5455e-d0be-4c2b-b9ab-458b5480ed571

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-3103-071335310300120 TABLET in 1 BOTTLE (71335-3103-0) 120 tablet2026-03-16NoNoHistorical
71335-3103-17133531030120 TABLET in 1 BOTTLE (71335-3103-1) 20 tablet2026-03-16NoNoHistorical
71335-3103-27133531030228 TABLET in 1 BOTTLE (71335-3103-2) 28 tablet2026-03-16NoNoHistorical
71335-3103-37133531030330 TABLET in 1 BOTTLE (71335-3103-3) 30 tablet2026-03-16NoNoHistorical
71335-3103-47133531030450 TABLET in 1 BOTTLE (71335-3103-4) 50 tablet2026-03-16NoNoHistorical
71335-3103-57133531030515 TABLET in 1 BOTTLE (71335-3103-5) 15 tablet2026-03-16NoNoHistorical
71335-3103-67133531030660 TABLET in 1 BOTTLE (71335-3103-6) 60 tablet2026-03-16NoNoHistorical
71335-3103-77133531030725 TABLET in 1 BOTTLE (71335-3103-7) 25 tablet2026-03-16NoNoHistorical
71335-3103-87133531030810 TABLET in 1 BOTTLE (71335-3103-8) 10 tablet2026-03-16NoNoHistorical
71335-3103-97133531030940 TABLET in 1 BOTTLE (71335-3103-9) 40 tablet2026-03-16NoNoHistorical