imiquimod

Generic: imiquimod

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imiquimod
Generic Name imiquimod
Labeler padagis israel pharmaceuticals ltd
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

imiquimod 12.5 mg/.25g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-368
Product ID 45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA078837
Listing Expiration 2026-12-31
Marketing Start 2010-11-09

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 45802368
Hyphenated Format 45802-368

Supplemental Identifiers

RxCUI
310982
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 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
  • 12 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET
  • 24 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKET
source: ndc

Packages (2)

45802-368-53 12 PACKET in 1 CARTON (45802-368-53) / .25 g in 1 PACKET 45802-368-62 24 PACKET in 1 CARTON (45802-368-62) / .25 g in 1 PACKET

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": "8a20139d-21d1-4182-b5aa-d59a05bf7600", "openfda": {"nui": ["N0000009267", "N0000009269", "N0000000157"], "unii": ["P1QW714R7M"], "rxcui": ["310982"], "spl_set_id": ["1505cf54-37da-4b2b-9812-6ffd6a01a7c7"], "pharm_class_pe": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]"], "pharm_class_moa": ["Interferon Inducers [MoA]"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 PACKET in 1 CARTON (45802-368-53)  / .25 g in 1 PACKET", "package_ndc": "45802-368-53", "marketing_start_date": "20120712"}, {"sample": false, "description": "24 PACKET in 1 CARTON (45802-368-62)  / .25 g in 1 PACKET", "package_ndc": "45802-368-62", "marketing_start_date": "20101109"}], "brand_name": "Imiquimod", "product_id": "45802-368_8a20139d-21d1-4182-b5aa-d59a05bf7600", "dosage_form": "CREAM", "pharm_class": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]", "Interferon Inducers [MoA]"], "product_ndc": "45802-368", "generic_name": "Imiquimod", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "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": "20101109", "listing_expiration_date": "20261231"}