erlotinib

Generic: erlotinib

Labeler: zydus lifesciences limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

erlotinib hydrochloride 150 mg/1

Manufacturer
Zydus Lifesciences Limited

Identifiers & Regulatory

Product NDC 70771-1523
Product ID 70771-1523_9d253beb-cd1f-45df-9b23-c521269d419f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA213065
Listing Expiration 2026-12-31
Marketing Start 2020-04-30

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 707711523
Hyphenated Format 70771-1523

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 ANDA213065 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (70771-1523-3)
  • 3 BLISTER PACK in 1 CARTON (70771-1523-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1523-2)
  • 90 TABLET, FILM COATED in 1 BOTTLE (70771-1523-9)
source: ndc

Packages (3)

70771-1523-3 30 TABLET, FILM COATED in 1 BOTTLE (70771-1523-3) 70771-1523-7 3 BLISTER PACK in 1 CARTON (70771-1523-7) / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1523-2) 70771-1523-9 90 TABLET, FILM COATED in 1 BOTTLE (70771-1523-9)

Ingredients (1)

erlotinib hydrochloride (150 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": "9d253beb-cd1f-45df-9b23-c521269d419f", "openfda": {"unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["daaa1329-3a3f-439c-b13d-b301daa234d4"], "manufacturer_name": ["Zydus Lifesciences Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (70771-1523-3)", "package_ndc": "70771-1523-3", "marketing_start_date": "20200430"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (70771-1523-7)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (70771-1523-2)", "package_ndc": "70771-1523-7", "marketing_start_date": "20200430"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (70771-1523-9)", "package_ndc": "70771-1523-9", "marketing_start_date": "20200430"}], "brand_name": "Erlotinib", "product_id": "70771-1523_9d253beb-cd1f-45df-9b23-c521269d419f", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "70771-1523", "generic_name": "Erlotinib", "labeler_name": "Zydus Lifesciences Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA213065", "marketing_category": "ANDA", "marketing_start_date": "20200430", "listing_expiration_date": "20261231"}