FDA.reportPublic FDA data

Acyclovir

Product NDC
62332-248
11-digit product format
623320248
Labeler code
62332
Product ID
62332-248_40ce38dc-e259-49e3-98e4-0f529b9ab17e
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Acyclovir
Dosage form
OINTMENT
Route
CUTANEOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA209000
Marketing category
ANDA
Marketing start
2025-03-27
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
Rxcui197312

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
62332-248-05Acyclovir5 g in 1 TUBEOINTMENT510
62332-248-05Acyclovir1 in 1 CARTONOINTMENT110
62332-248-15Acyclovir1 in 1 CARTONOINTMENT110
62332-248-15Acyclovir15 g in 1 TUBEOINTMENT1510
62332-248-30Acyclovir1 in 1 CARTONOINTMENT110
62332-248-30Acyclovir30 g in 1 TUBEOINTMENT3010

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-248ACYCLOVIR OINTMENT [ALEMBIC PHARMACEUTICALS INC.]10Current NDC, Legacy NDC, 6 package rows20250330_5adf2205-5493-4e7a-bf50-01f4eb661dd8.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
197312acyclovir 5 % Topical OintmentPSN5adf2205-5493-4e7a-bf50-01f4eb661dd810
197312acyclovir 0.05 MG/MG Topical OintmentSCD5adf2205-5493-4e7a-bf50-01f4eb661dd810
197312acyclovir 5 % Topical OintmentSY5adf2205-5493-4e7a-bf50-01f4eb661dd810
197312acyclovir 50 MG per 1 GM Topical OintmentSY5adf2205-5493-4e7a-bf50-01f4eb661dd810
197312acycycloguanosine 0.05 MG/MG Topical OintmentSY5adf2205-5493-4e7a-bf50-01f4eb661dd810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
62332-248-05623320248051 TUBE in 1 CARTON (62332-248-05) / 5 g in 1 TUBE1 tube2025-03-270000-00-00NoNoCurrent
62332-248-15623320248151 TUBE in 1 CARTON (62332-248-15) / 15 g in 1 TUBE1 tube2025-03-270000-00-00NoNoCurrent
62332-248-30623320248301 TUBE in 1 CARTON (62332-248-30) / 30 g in 1 TUBE1 tube2025-03-270000-00-00NoNoCurrent