Imiquimod

Product NDC
51672-4145
11-digit product format
516724145
Labeler code
51672
Product ID
51672-4145_3c178924-2055-ce8d-e063-6294a90a644f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Sun Pharmaceutical Industries, Inc.
Application
ANDA200173
Marketing category
ANDA
Marketing start
2011-04-15
Substance
IMIQUIMOD
Active strength
50 mg/g
Pharmacologic classes
Increased Cytokine Activity [PE], Increased Cytokine Production [PE], Interferon Inducers [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Imiquimod
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIQUIMOD50 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP1QW714R7M
Rxcui310982

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
51672-4145-6Imiquimod24 in 1 CARTONCREAM2411
51672-4145-8Imiquimod0.25 g in 1 PACKETCREAM0.2511

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-4145-6EA - Each51672-41450a99dc7f-1cea-479d-b2a6-bd0d969af46412012-07-24
51672-4145-8EA - Each51672-414585c09fd2-7dc0-4439-b7e7-1367b732c75212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51672-4145IMIQUIMOD CREAM [SUN PHARMACEUTICAL INDUSTRIES, INC.]8Current NDC, Legacy NDC, 2 package rows20250406_59af8153-4cf8-4f22-9000-f239798d52d1.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310982imiquimod 5 % Topical CreamPSN59af8153-4cf8-4f22-9000-f239798d52d111
310982imiquimod 50 MG/ML Topical CreamSCD59af8153-4cf8-4f22-9000-f239798d52d111
310982imiquimod 5 % Topical CreamSY59af8153-4cf8-4f22-9000-f239798d52d111

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
51672-4145-65167241450624 PACKET in 1 CARTON (51672-4145-6) / .25 g in 1 PACKET (51672-4145-8) 24 packet2011-04-150000-00-00NoNoCurrent
51672-4145-8516724145080.25 g in 1 PACKET0.25 gHistorical