erlotinib

Generic: erlotinib

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erlotinib
Generic Name erlotinib
Labeler aurobindo pharma limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erlotinib hydrochloride 25 mg/1

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-530
Product ID 59651-530_3ecafc1e-979a-4aff-a276-18fc0b110491
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA216342
Listing Expiration 2026-12-31
Marketing Start 2022-06-22

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651530
Hyphenated Format 59651-530

Supplemental Identifiers

RxCUI
603203 603206 603208
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 (source: ndc)
Application Number ANDA216342 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (59651-530-03)
  • 1 BLISTER PACK in 1 CARTON (59651-530-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK
source: ndc

Packages (2)

59651-530-03 30 TABLET, FILM COATED in 1 BOTTLE (59651-530-03) 59651-530-10 1 BLISTER PACK in 1 CARTON (59651-530-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK

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": "3ecafc1e-979a-4aff-a276-18fc0b110491", "openfda": {"unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["3ecafc1e-979a-4aff-a276-18fc0b110491"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (59651-530-03)", "package_ndc": "59651-530-03", "marketing_start_date": "20220622"}, {"sample": false, "description": "1 BLISTER PACK in 1 CARTON (59651-530-10)  / 10 TABLET, FILM COATED in 1 BLISTER PACK", "package_ndc": "59651-530-10", "marketing_start_date": "20220622"}], "brand_name": "Erlotinib", "product_id": "59651-530_3ecafc1e-979a-4aff-a276-18fc0b110491", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "59651-530", "generic_name": "Erlotinib", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA216342", "marketing_category": "ANDA", "marketing_start_date": "20220622", "listing_expiration_date": "20261231"}