zyclara

Generic: imiquimod

Labeler: bausch health us, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name zyclara
Generic Name imiquimod
Labeler bausch health us, llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

imiquimod 37.5 mg/g

Manufacturer
Bausch Health US, LLC

Identifiers & Regulatory

Product NDC 99207-270
Product ID 99207-270_1216e839-274f-412d-953f-ce56f0cd42a2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022483
Listing Expiration 2027-12-31
Marketing Start 2011-11-28

Pharmacologic Class

Mechanism of Action
interferon inducers [moa]
Physiologic Effect
increased cytokine activity [pe] increased cytokine production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 99207270
Hyphenated Format 99207-270

Supplemental Identifiers

RxCUI
967017 967021
UNII
P1QW714R7M
NUI
N0000009267 N0000009269 N0000000157

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name zyclara (source: ndc)
Generic Name imiquimod (source: ndc)
Application Number NDA022483 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 37.5 mg/g
source: ndc
Packaging
  • 4 PACKET in 1 CARTON (99207-270-01) / .25 g in 1 PACKET
source: ndc

Packages (1)

99207-270-01 4 PACKET in 1 CARTON (99207-270-01) / .25 g in 1 PACKET

Ingredients (1)

imiquimod (37.5 mg/g)

Linked Drug Pages (1)

Zyclara ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1216e839-274f-412d-953f-ce56f0cd42a2", "openfda": {"nui": ["N0000009267", "N0000009269", "N0000000157"], "unii": ["P1QW714R7M"], "rxcui": ["967017", "967021"], "spl_set_id": ["28cd9b5b-680b-480f-b33d-9c5b52bbf03d"], "pharm_class_pe": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]"], "pharm_class_moa": ["Interferon Inducers [MoA]"], "manufacturer_name": ["Bausch Health US, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "4 PACKET in 1 CARTON (99207-270-01)  / .25 g in 1 PACKET", "package_ndc": "99207-270-01", "marketing_start_date": "20111128"}], "brand_name": "Zyclara", "product_id": "99207-270_1216e839-274f-412d-953f-ce56f0cd42a2", "dosage_form": "CREAM", "pharm_class": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]", "Interferon Inducers [MoA]"], "product_ndc": "99207-270", "generic_name": "imiquimod", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zyclara", "active_ingredients": [{"name": "IMIQUIMOD", "strength": "37.5 mg/g"}], "application_number": "NDA022483", "marketing_category": "NDA", "marketing_start_date": "20111128", "listing_expiration_date": "20271231"}