FDA.reportPublic FDA data

Acyclovir

Product NDC
72578-101
11-digit product format
725780101
Labeler code
72578
Product ID
72578-101_611d8237-2516-413c-81c3-99252bb5f597
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Viona Pharmaceuticals Inc
Application
ANDA206770
Marketing category
ANDA
Marketing start
2023-03-03
Substance
ACYCLOVIR
Active strength
50 mg/g
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
ACYCLOVIR50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiX4HES1O11F
Rxcui141859

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
72578-101-04Acyclovir2 g in 1 TUBECREAM23
72578-101-04Acyclovir1 in 1 CARTONCREAM13
72578-101-05Acyclovir5 g in 1 TUBECREAM53
72578-101-05Acyclovir1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72578-101ACYCLOVIR CREAM [VIONA PHARMACEUTICALS INC]3Current NDC, 4 package rows20241208_a2966b6d-c6c0-4afd-8eda-045df497cb9d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSNa2966b6d-c6c0-4afd-8eda-045df497cb9d3
141859acyclovir 50 MG/ML Topical CreamSCDa2966b6d-c6c0-4afd-8eda-045df497cb9d3
141859acyclovir 5 % Topical CreamSYa2966b6d-c6c0-4afd-8eda-045df497cb9d3
141859acycycloguanosine 50 MG/ML Topical CreamSYa2966b6d-c6c0-4afd-8eda-045df497cb9d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72578-101-04725780101041 TUBE in 1 CARTON (72578-101-04) / 2 g in 1 TUBE1 tube2023-03-03NoNoCurrent
72578-101-05725780101051 TUBE in 1 CARTON (72578-101-05) / 5 g in 1 TUBE1 tube2023-03-03NoNoCurrent