erlotinib

Generic: erlotinib

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

Drug Facts

Product Profile

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

erlotinib hydrochloride 150 mg/1

Manufacturer
Teva Pharmaceuticals USA, Inc.

Identifiers & Regulatory

Product NDC 0093-7664
Product ID 0093-7664_4368f7b2-5bdb-4232-90b0-f6a769d71e9b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA091059
Listing Expiration 2026-12-31
Marketing Start 2019-05-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00937664
Hyphenated Format 0093-7664

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 ANDA091059 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 150 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (0093-7664-56)
source: ndc

Packages (1)

0093-7664-56 30 TABLET, FILM COATED in 1 BOTTLE (0093-7664-56)

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": "4368f7b2-5bdb-4232-90b0-f6a769d71e9b", "openfda": {"unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["5d97f401-4853-4a9a-907d-21e8a4d16088"], "manufacturer_name": ["Teva Pharmaceuticals USA, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (0093-7664-56)", "package_ndc": "0093-7664-56", "marketing_start_date": "20190509"}], "brand_name": "Erlotinib", "product_id": "0093-7664_4368f7b2-5bdb-4232-90b0-f6a769d71e9b", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "0093-7664", "generic_name": "Erlotinib", "labeler_name": "Teva Pharmaceuticals USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "150 mg/1"}], "application_number": "ANDA091059", "marketing_category": "ANDA", "marketing_start_date": "20190509", "listing_expiration_date": "20261231"}