Imiquimod

Product NDC
51672-4174
11-digit product format
516724174
Labeler code
51672
Product ID
51672-4174_48e9d045-e9a2-8452-e063-6294a90af1e9
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA205971
Marketing category
ANDA
Marketing start
2021-01-26
Substance
IMIQUIMOD
Active strength
37.5 mg/g
Pharmacologic classes
Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imiquimod
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIQUIMOD37.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP1QW714R7M
Rxcui967017

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5624e12d-8450-453b-aa8d-acacc0adf764Product name120210621
b519e8a5-29e1-d8cd-ace0-3915cc880d8fProduct name220150122

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-4174-6Imiquimod28 in 1 CARTONCREAM288
51672-4174-8Imiquimod0.25 g in 1 PACKETCREAM0.258
51672-4174-9Imiquimod7.5 g in 1 BOTTLE, PUMPCREAM7.58
51672-4174-9Imiquimod1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4174-6EA - Each51672-4174ccb3f184-ea05-4d8e-a928-c6a13d925b4812021-02-05
51672-4174-9GM - Gram51672-4174c82311f3-d4b6-40ea-8aa9-58d84fe4bddc12021-12-08

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4174IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]6Current NDC, Legacy NDC, 4 package rows20250406_51913a5a-1cab-4b9e-b2c2-e0174062df73.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967017imiquimod 3.75 % Topical CreamPSN51913a5a-1cab-4b9e-b2c2-e0174062df738
967017imiquimod 37.5 MG/ML Topical CreamSCD51913a5a-1cab-4b9e-b2c2-e0174062df738
967017imiquimod 3.75 % Topical CreamSY51913a5a-1cab-4b9e-b2c2-e0174062df738

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4174-65167241740628 PACKET in 1 CARTON (51672-4174-6) / .25 g in 1 PACKET (51672-4174-8) 28 packet2021-01-260000-00-00NoNoCurrent
51672-4174-8516724174080.25 g in 1 PACKET0.25 gHistorical
51672-4174-9516724174091 BOTTLE, PUMP in 1 CARTON (51672-4174-9) / 7.5 g in 1 BOTTLE, PUMP2021-10-140000-00-00NoNoCurrent