FDA.reportPublic FDA data

Acyclovir

Product NDC
51672-1361
11-digit product format
516721361
Labeler code
51672
Product ID
51672-1361_38ef59f9-e15c-3123-e063-6294a90a85e2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205470
Marketing category
ANDA
Marketing start
2024-06-13
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
51672-1361-5Acyclovir1 in 1 CARTONCREAM16
51672-1361-5Acyclovir5 g in 1 TUBECREAM56
51672-1361-9Acyclovir1 in 1 CARTONCREAM16
51672-1361-9Acyclovir2 g in 1 TUBECREAM26

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1361-5GM - Gram51672-13611cc77fc7-f5db-45a6-af2f-90518cfb3f5812024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-1361ACYCLOVIR CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]5Current NDC, 4 package rows20250406_6e3b04a8-47a4-425e-931e-9a4fa260b303.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSN6e3b04a8-47a4-425e-931e-9a4fa260b3036
141859acyclovir 50 MG/ML Topical CreamSCD6e3b04a8-47a4-425e-931e-9a4fa260b3036
141859acyclovir 5 % Topical CreamSY6e3b04a8-47a4-425e-931e-9a4fa260b3036
141859acycycloguanosine 50 MG/ML Topical CreamSY6e3b04a8-47a4-425e-931e-9a4fa260b3036

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51672-1361-5516721361051 TUBE in 1 CARTON (51672-1361-5) / 5 g in 1 TUBE1 tube2024-06-13NoNoHistorical
51672-1361-9516721361091 TUBE in 1 CARTON (51672-1361-9) / 2 g in 1 TUBE1 tube2024-06-13NoNoHistorical