erlotinib

Generic: erlotinib hydrochloride

Labeler: armas pharmaceuticals inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erlotinib
Generic Name erlotinib hydrochloride
Labeler armas pharmaceuticals inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erlotinib hydrochloride 25 mg/1

Manufacturer
Armas Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 72485-217
Product ID 72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA211960
Listing Expiration 2026-12-31
Marketing Start 2019-11-06

Pharmacologic Class

Classes
kinase inhibitor [epc] protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72485217
Hyphenated Format 72485-217

Supplemental Identifiers

RxCUI
603208
UPC
0372485217304
UNII
DA87705X9K

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 erlotinib (source: ndc)
Generic Name erlotinib hydrochloride (source: ndc)
Application Number ANDA211960 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

72485-217-30 1 BOTTLE in 1 BOX (72485-217-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Ingredients (1)

erlotinib hydrochloride (25 mg/1)

Linked Drug Pages (1)

Erlotinib ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "35e3a161-752e-4479-b27c-3dc8efd3ca9e", "openfda": {"upc": ["0372485217304"], "unii": ["DA87705X9K"], "rxcui": ["603208"], "spl_set_id": ["53cf8868-cfd8-4c6e-ad9d-3171ff1e4d8c"], "manufacturer_name": ["Armas Pharmaceuticals Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 BOX (72485-217-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72485-217-30", "marketing_start_date": "20191106"}], "brand_name": "Erlotinib", "product_id": "72485-217_35e3a161-752e-4479-b27c-3dc8efd3ca9e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "72485-217", "generic_name": "Erlotinib hydrochloride", "labeler_name": "Armas Pharmaceuticals Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA211960", "marketing_category": "ANDA", "marketing_start_date": "20191106", "listing_expiration_date": "20261231"}