FDA.reportPublic FDA data

Zyclara

Product NDC
99207-276
11-digit product format
992070276
Labeler code
99207
Product ID
99207-276_1216e839-274f-412d-953f-ce56f0cd42a2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
imiquimod
Dosage form
CREAM
Route
TOPICAL
Labeler
Bausch Health US, LLC
Application
NDA022483
Marketing category
NDA
Marketing start
2012-02-29
Substance
IMIQUIMOD
Active strength
2.5 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
Zyclara
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IMIQUIMOD2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP1QW714R7M
Rxcui967017, 967021

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
99207-276-01Zyclara7.5 g in 1 BOTTLE, PUMPCREAM7.523
99207-276-01Zyclara1 in 1 CARTONCREAM123
99207-276-75Zyclara7.5 g in 1 BOTTLE, PUMPCREAM7.523
99207-276-75Zyclara1 in 1 CARTONCREAM123

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
99207-276-75GM - Gram99207-27612d30b8c-bb05-46af-9bb0-339417dfcf2412013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
imiquimodACTIVE INGREDIENTP1QW714R7MZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
imiquimodACTIVE MOIETYP1QW714R7MZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
ISOSTEARIC ACIDINACTIVE INGREDIENTX33R8U0062ZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OHZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
SORBITAN MONOSTEARATEINACTIVE INGREDIENTNVZ4I0H58XZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
STEARYL ALCOHOLINACTIVE INGREDIENT2KR89I4H1YZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
WATERINACTIVE INGREDIENT059QF0KO0RZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEZYCLARA (IMIQUIMOD) CREAM [MEDICIS PHARMACEUTICAL CORP]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99207-276ZYCLARA (IMIQUIMOD) CREAM [BAUSCH HEALTH US, LLC]22Current NDC, Legacy NDC, 4 package rows20250525_28cd9b5b-680b-480f-b33d-9c5b52bbf03d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
967017imiquimod 3.75 % Topical CreamPSN28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967021Zyclara 3.75 % Topical CreamPSN28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967021imiquimod 37.5 MG/ML Topical Cream [Zyclara]SBD28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967017imiquimod 37.5 MG/ML Topical CreamSCD28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967017imiquimod 3.75 % Topical CreamSY28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967021Zyclara 3.75 % Topical CreamSY28cd9b5b-680b-480f-b33d-9c5b52bbf03d23
967021Zyclara 37.5 MG/ML Topical CreamSY28cd9b5b-680b-480f-b33d-9c5b52bbf03d23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
99207-276-01992070276011 BOTTLE, PUMP in 1 CARTON (99207-276-01) / 7.5 g in 1 BOTTLE, PUMP2012-02-290000-00-00NoNoCurrent
99207-276-75992070276751 BOTTLE, PUMP in 1 CARTON (99207-276-75) > 7.5 g in 1 BOTTLE, PUMP2012-02-290000-00-00NoNoCurrent