imiquimod

Generic: imiquimod

Labeler: glenmark pharmaceuticals inc., usa
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name imiquimod
Generic Name imiquimod
Labeler glenmark pharmaceuticals inc., usa
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

imiquimod 50 mg/g

Manufacturer
Glenmark Pharmaceuticals Inc., USA

Identifiers & Regulatory

Product NDC 68462-536
Product ID 68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA201994
Listing Expiration 2027-12-31
Marketing Start 2012-03-06

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 68462536
Hyphenated Format 68462-536

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 ANDA201994 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 50 mg/g
source: ndc
Packaging
  • 24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01)
source: ndc

Packages (1)

68462-536-70 24 PACKET in 1 CARTON (68462-536-70) / .25 g in 1 PACKET (68462-536-01)

Ingredients (1)

imiquimod (50 mg/g)

Linked Drug Pages (1)

Imiquimod ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc", "openfda": {"nui": ["N0000009267", "N0000009269", "N0000000157"], "unii": ["P1QW714R7M"], "rxcui": ["310982"], "spl_set_id": ["663e39a9-a29e-473f-89ec-4c7c6bc27b8a"], "pharm_class_pe": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]"], "pharm_class_moa": ["Interferon Inducers [MoA]"], "manufacturer_name": ["Glenmark Pharmaceuticals Inc., USA"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "24 PACKET in 1 CARTON (68462-536-70)  / .25 g in 1 PACKET (68462-536-01)", "package_ndc": "68462-536-70", "marketing_start_date": "20120306"}], "brand_name": "Imiquimod", "product_id": "68462-536_be827b5b-c3e8-4ec3-a8b0-a745e29f8ebc", "dosage_form": "CREAM", "pharm_class": ["Increased Cytokine Activity [PE]", "Increased Cytokine Production [PE]", "Interferon Inducers [MoA]"], "product_ndc": "68462-536", "generic_name": "Imiquimod", "labeler_name": "Glenmark Pharmaceuticals Inc., USA", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Imiquimod", "active_ingredients": [{"name": "IMIQUIMOD", "strength": "50 mg/g"}], "application_number": "ANDA201994", "marketing_category": "ANDA", "marketing_start_date": "20120306", "listing_expiration_date": "20271231"}