imiquimod

Generic: imiquimod

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imiquimod
Generic Name imiquimod
Labeler direct rx
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

imiquimod 12.5 mg/.25g

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 72189-084
Product ID 72189-084_2be84443-5bdd-96bd-e063-6294a90a9264
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078837
Listing Expiration 2026-12-31
Marketing Start 2020-03-23

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 72189084
Hyphenated Format 72189-084

Supplemental Identifiers

RxCUI
310982
UNII
P1QW714R7M
NUI
N0000009267 N0000009269 N0000000157

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 imiquimod (source: ndc)
Generic Name imiquimod (source: ndc)
Application Number ANDA078837 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 12.5 mg/.25g
source: ndc
Packaging
  • .25 g in 1 PACKET (72189-084-24)
source: ndc

Packages (1)

72189-084-24 .25 g in 1 PACKET (72189-084-24)

Ingredients (1)

imiquimod (12.5 mg/.25g)

Linked Drug Pages (1)

IMIQUIMOD ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2be84443-5bdd-96bd-e063-6294a90a9264", "openfda": {"nui": ["N0000009267", "N0000009269", "N0000000157"], "unii": ["P1QW714R7M"], "rxcui": ["310982"], "spl_set_id": ["a18a3f7e-7254-56c0-e053-2a95a90a7036"], "pharm_class_pe": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]"], "pharm_class_moa": ["Interferon Inducers [MoA]"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": ".25 g in 1 PACKET (72189-084-24)", "package_ndc": "72189-084-24", "marketing_start_date": "20200323"}], "brand_name": "IMIQUIMOD", "product_id": "72189-084_2be84443-5bdd-96bd-e063-6294a90a9264", "dosage_form": "CREAM", "pharm_class": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]", "Interferon Inducers [MoA]"], "product_ndc": "72189-084", "generic_name": "IMIQUIMOD", "labeler_name": "DIRECT RX", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "IMIQUIMOD", "active_ingredients": [{"name": "IMIQUIMOD", "strength": "12.5 mg/.25g"}], "application_number": "ANDA078837", "marketing_category": "ANDA", "marketing_start_date": "20200323", "listing_expiration_date": "20261231"}