FDA.reportPublic FDA data

ACYCLOVIR

Product NDC
62332-423
11-digit product format
623320423
Labeler code
62332
Product ID
62332-423_ef882383-ae44-4dcc-a0fd-6e3ee971b57f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ACYCLOVIR
Dosage form
CREAM
Route
TOPICAL
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA212361
Marketing category
ANDA
Marketing start
2023-11-27
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
62332-423-05ACYCLOVIR5 g in 1 TUBECREAM54
62332-423-05ACYCLOVIR1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62332-423-05GM - Gram62332-423726c4027-beeb-4228-bffa-5f7afeb41eda12023-12-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-423ACYCLOVIR CREAM [ALEMBIC PHARMACEUTICALS INC.]4Current NDC, 2 package rows20231128_878615c2-09ea-44ce-8c30-7a7f16acb20c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
141859acyclovir 5 % Topical CreamPSN878615c2-09ea-44ce-8c30-7a7f16acb20c4
141859acyclovir 50 MG/ML Topical CreamSCD878615c2-09ea-44ce-8c30-7a7f16acb20c4
141859acyclovir 5 % Topical CreamSY878615c2-09ea-44ce-8c30-7a7f16acb20c4
141859acycycloguanosine 50 MG/ML Topical CreamSY878615c2-09ea-44ce-8c30-7a7f16acb20c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-423-05623320423051 TUBE in 1 CARTON (62332-423-05) / 5 g in 1 TUBE1 tube2023-11-27NoNoCurrent