FDA.reportPublic FDA data

acyclovir

Product NDC
71335-2261
11-digit product format
713352261
Labeler code
71335
Product ID
71335-2261_1bed7dd6-b341-487f-8cdb-45c1d7906e32
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
acyclovir
Dosage form
CAPSULE
Route
ORAL
Labeler
Bryant Ranch Prepack
Application
ANDA204313
Marketing category
ANDA
Marketing start
2019-08-23
Substance
ACYCLOVIR
Active strength
200 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
ACYCLOVIR200 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui197310

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
71335-2261-0acyclovir90 in 1 BOTTLECAPSULE90101
71335-2261-1acyclovir30 in 1 BOTTLECAPSULE30101
71335-2261-2acyclovir25 in 1 BOTTLECAPSULE25101
71335-2261-3acyclovir35 in 1 BOTTLECAPSULE35101
71335-2261-4acyclovir50 in 1 BOTTLECAPSULE50101
71335-2261-5acyclovir100 in 1 BOTTLECAPSULE100101
71335-2261-6acyclovir40 in 1 BOTTLECAPSULE40101
71335-2261-7acyclovir60 in 1 BOTTLECAPSULE60101
71335-2261-8acyclovir120 in 1 BOTTLECAPSULE120101
71335-2261-9acyclovir20 in 1 BOTTLECAPSULE20101

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2261ACYCLOVIR CAPSULE [BRYANT RANCH PREPACK]100Current NDC, 10 package rows20231031_c818e86c-a4d0-48cd-a888-fa1ee9e2aa19.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197310acyclovir 200 MG Oral CapsulePSNc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acyclovir 200 MG Oral CapsuleSCDc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101
197310acycycloguanosine 200 MG Oral CapsuleSYc818e86c-a4d0-48cd-a888-fa1ee9e2aa19101

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2261-07133522610090 CAPSULE in 1 BOTTLE (71335-2261-0) 90 capsule2023-10-27NoNoHistorical
71335-2261-17133522610130 CAPSULE in 1 BOTTLE (71335-2261-1) 30 capsule2023-10-27NoNoHistorical
71335-2261-27133522610225 CAPSULE in 1 BOTTLE (71335-2261-2) 25 capsule2023-10-27NoNoHistorical
71335-2261-37133522610335 CAPSULE in 1 BOTTLE (71335-2261-3) 35 capsule2023-10-27NoNoHistorical
71335-2261-47133522610450 CAPSULE in 1 BOTTLE (71335-2261-4) 50 capsule2023-10-27NoNoHistorical
71335-2261-571335226105100 CAPSULE in 1 BOTTLE (71335-2261-5) 100 capsule2023-10-27NoNoHistorical
71335-2261-67133522610640 CAPSULE in 1 BOTTLE (71335-2261-6) 40 capsule2023-10-27NoNoHistorical
71335-2261-77133522610760 CAPSULE in 1 BOTTLE (71335-2261-7) 60 capsule2023-10-27NoNoHistorical
71335-2261-871335226108120 CAPSULE in 1 BOTTLE (71335-2261-8) 120 capsule2023-10-27NoNoHistorical
71335-2261-97133522610920 CAPSULE in 1 BOTTLE (71335-2261-9) 20 capsule2023-10-27NoNoHistorical