Zyclara

Generic: imiquimod

Labeler: Bausch Health US, LLC
NDC Directory HUMAN PRESCRIPTION DRUG NDA Active

Drug Facts

Product Profile

Brand Name Zyclara
Generic Name imiquimod
Labeler Bausch Health US, LLC
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

IMIQUIMOD 2.5 mg/g

Identifiers & Regulatory

Product NDC 99207-276
Product ID 99207-276_35d3eb43-c6ef-f3ab-e063-6294a90a0891
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA022483
Listing Expiration 2026-12-31
Marketing Start 2012-02-29

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 99207276
Hyphenated Format 99207-276

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
  • 2.5 mg/g
source: ndc
Packaging
  • 1 BOTTLE, PUMP in 1 CARTON (99207-276-01) / 7.5 g in 1 BOTTLE, PUMP
  • 1 BOTTLE, PUMP in 1 CARTON (99207-276-75) / 7.5 g in 1 BOTTLE, PUMP
source: ndc

Packages (2)

99207-276-01 1 BOTTLE, PUMP in 1 CARTON (99207-276-01) / 7.5 g in 1 BOTTLE, PUMP 99207-276-75 1 BOTTLE, PUMP in 1 CARTON (99207-276-75) / 7.5 g in 1 BOTTLE, PUMP

Ingredients (1)

IMIQUIMOD (2.5 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": "35d3eb43-c6ef-f3ab-e063-6294a90a0891", "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": "1 BOTTLE, PUMP in 1 CARTON (99207-276-01)  / 7.5 g in 1 BOTTLE, PUMP", "package_ndc": "99207-276-01", "marketing_start_date": "20120229"}, {"sample": false, "description": "1 BOTTLE, PUMP in 1 CARTON (99207-276-75)  / 7.5 g in 1 BOTTLE, PUMP", "package_ndc": "99207-276-75", "marketing_start_date": "20120229"}], "brand_name": "Zyclara", "product_id": "99207-276_35d3eb43-c6ef-f3ab-e063-6294a90a0891", "dosage_form": "CREAM", "pharm_class": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]", "Interferon Inducers [MoA]"], "product_ndc": "99207-276", "generic_name": "imiquimod", "labeler_name": "Bausch Health US, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Zyclara", "active_ingredients": [{"name": "IMIQUIMOD", "strength": "2.5 mg/g"}], "application_number": "NDA022483", "marketing_category": "NDA", "marketing_start_date": "20120229", "listing_expiration_date": "20261231"}