Imiquimod

Product NDC
0093-3133
11-digit product format
000933133
Labeler code
0093
Product ID
0093-3133_38cf079b-29a3-e85d-e063-6294a90aece1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Teva Pharmaceuticals USA, Inc.
Application
NDA022483
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2020-07-30
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
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
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
0093-3133-31Imiquimod1 in 1 CARTONCREAM15
0093-3133-31Imiquimod7.5 g in 1 BOTTLE, PUMPCREAM7.55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0093-3133-31GM - Gram0093-3133e864efda-d801-4bcc-aa85-18dfafa41a9212020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0093-3133IMIQUIMOD CREAM [TEVA PHARMACEUTICALS USA, INC.]4Current NDC, Legacy NDC, 2 package rows20210427_9f2cbefd-f295-47e2-8a9e-3e7c5812c963.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967017imiquimod 3.75 % Topical CreamPSN9f2cbefd-f295-47e2-8a9e-3e7c5812c9635
967017imiquimod 37.5 MG/ML Topical CreamSCD9f2cbefd-f295-47e2-8a9e-3e7c5812c9635
967017imiquimod 3.75 % Topical CreamSY9f2cbefd-f295-47e2-8a9e-3e7c5812c9635

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0093-3133-31000933133311 BOTTLE, PUMP in 1 CARTON (0093-3133-31) / 7.5 g in 1 BOTTLE, PUMP2020-07-300000-00-00NoNoCurrent