FDA.reportPublic FDA data

Imiquimod

Product NDC
45802-368
11-digit product format
458020368
Labeler code
45802
Product ID
45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Padagis Israel Pharmaceuticals Ltd
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
45802-368-53Imiquimod0.25 g in 1 PACKETCREAM0.2513
45802-368-53Imiquimod12 in 1 CARTONCREAM1213
45802-368-62Imiquimod24 in 1 CARTONCREAM2413
45802-368-62Imiquimod0.25 g in 1 PACKETCREAM0.2513

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
45802-368-53EA - Each45802-36885fa9135-afcc-4a39-9bec-2bc57c50beca12013-02-13
45802-368-62EA - Each45802-368ab255ea7-bdee-434a-ab15-10da04c8d39312012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IMIQUIMODACTIVE INGREDIENTP1QW714R7MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
IMIQUIMODACTIVE MOIETYP1QW714R7MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
GLYCERININACTIVE INGREDIENTPDC6A3C0OXIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
OLEIC ACIDINACTIVE INGREDIENT2UMI9U37CPIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
OLEYL ALCOHOLINACTIVE INGREDIENT172F2WN8DVIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
WATERINACTIVE INGREDIENT059QF0KO0RIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEIMIQUIMOD CREAM [PERRIGO NEW YORK INC]6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
45802-368IMIQUIMOD CREAM [PADAGIS ISRAEL PHARMACEUTICALS LTD]13Current NDC, Legacy NDC, 4 package rows20250228_1505cf54-37da-4b2b-9812-6ffd6a01a7c7.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
310982imiquimod 5 % Topical CreamPSN47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 5 % Topical CreamPSN9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 50 MG/ML Topical CreamSCD47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 50 MG/ML Topical CreamSCD9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 5 % Topical CreamSY47d3045f-a145-4095-bb8a-c67ba1ff3bda100
310982imiquimod 5 % Topical CreamSY9291e5cd-b83d-4b43-88f5-30cac6cef5ff100
310982imiquimod 5 % Topical CreamPSN1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 50 MG/ML Topical CreamSCD1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 5 % Topical CreamSY1505cf54-37da-4b2b-9812-6ffd6a01a7c713
310982imiquimod 5 % Topical CreamPSNf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 50 MG/ML Topical CreamSCDf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 5 % Topical CreamSYf8db59e2-8052-413b-9f9f-07cd9eea07ec3
310982imiquimod 5 % Topical CreamPSNa18a3f7e-7254-56c0-e053-2a95a90a70362
310982imiquimod 50 MG/ML Topical CreamSCDa18a3f7e-7254-56c0-e053-2a95a90a70362
310982imiquimod 5 % Topical CreamSYa18a3f7e-7254-56c0-e053-2a95a90a70362

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
45802-368-534580203685312 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET12 packet2012-07-120000-00-00NoNoCurrent
45802-368-624580203686224 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKET24 packet2010-11-090000-00-00NoNoCurrent