FDA.reportPublic FDA data

acyclovir

Product NDC
67296-1707
11-digit product format
672961707
Labeler code
67296
Product ID
67296-1707_f3bb3950-5149-3135-e053-2a95a90ad896
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
TABLET
Route
ORAL
Labeler
RedPharm Drug
Application
ANDA077309
Marketing category
ANDA
Marketing start
2007-06-09
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
67296-1707-2acyclovir20 in 1 BOTTLETABLET204
67296-1707-7acyclovir15 in 1 BOTTLETABLET154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67296-1707ACYCLOVIR TABLET [REDPHARM DRUG]4Current NDC, Legacy NDC, 2 package rows20230203_b2e8dafd-c9b6-ff73-e053-2995a90a1659.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197311acyclovir 400 MG Oral TabletPSNb2e8dafd-c9b6-ff73-e053-2995a90a16594
197311acyclovir 400 MG Oral TabletSCDb2e8dafd-c9b6-ff73-e053-2995a90a16594
197311acycycloguanosine 400 MG Oral TabletSYb2e8dafd-c9b6-ff73-e053-2995a90a16594

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67296-1707-26729617070220 TABLET in 1 BOTTLE (67296-1707-2) 20 tablet2007-06-090000-00-00NoNoCurrent
67296-1707-76729617070715 TABLET in 1 BOTTLE (67296-1707-7) 15 tablet2007-06-09NoNoCurrent