Zyclara

Product NDC
99207-270
11-digit product format
992070270
Labeler code
99207
Product ID
99207-270_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
2011-11-28
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
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
IMIQUIMOD37.5 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
99207-270-01Zyclara0.25 g in 1 PACKETCREAM0.2523
99207-270-01Zyclara4 in 1 CARTONCREAM423
99207-270-28Zyclara28 in 1 CARTONCREAM2823
99207-270-28Zyclara0.25 g in 1 PACKETCREAM0.2523

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
99207-270-28EA - Each99207-27042f34826-40f7-4043-9fe9-8f37b63f574212012-07-24

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
99207-270ZYCLARA (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 formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
99207-270-01992070270014 PACKET in 1 CARTON (99207-270-01) / .25 g in 1 PACKET4 packet2011-11-280000-00-00NoNoCurrent
99207-270-289920702702828 PACKET in 1 CARTON (99207-270-28) > .25 g in 1 PACKET28 packet2011-11-280000-00-00NoNoCurrent