Imiquimod

Product NDC
71335-2725
11-digit product format
713352725
Labeler code
71335
Product ID
71335-2725_08ed5b03-8ed3-40df-91de-404b9c743462
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
ANDA078837
Marketing category
ANDA
Marketing start
2010-11-09
Substance
IMIQUIMOD
Active strength
12.5 mg/.25g
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
IMIQUIMOD12.5 mg/.25g

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-2725-1Imiquimod0.25 g in 1 PACKETCREAM0.25100
71335-2725-1Imiquimod24 in 1 CARTONCREAM24100

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2725-1EA - Each71335-272509e4e59c-bdca-4293-b204-8fcb5171c06d12025-09-12

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310982imiquimod 5 % Topical CreamPSN47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 50 MG/ML Topical CreamSCD47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 5 % Topical CreamSY47d3045f-a145-4095-bb8a-c67ba1ff3bda100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71335-2725-17133527250124 PACKET in 1 CARTON (71335-2725-1) / .25 g in 1 PACKET24 packet2025-07-30NoNoHistorical