erlotinib hydrochloride

Generic: erlotinib hydrochloride

Labeler: alembic pharmaceuticals limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erlotinib hydrochloride
Generic Name erlotinib hydrochloride
Labeler alembic pharmaceuticals limited
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erlotinib hydrochloride 100 mg/1

Manufacturer
Alembic Pharmaceuticals Limited

Identifiers & Regulatory

Product NDC 46708-566
Product ID 46708-566_966e67f7-6259-4b1c-8c6a-b2589d57e1ed
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214719
Listing Expiration 2026-12-31
Marketing Start 2021-07-09

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 46708566
Hyphenated Format 46708-566

Supplemental Identifiers

RxCUI
603203 603206 603208
UPC
0346708567309 0346708566302 0346708565305
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 hydrochloride (source: ndc)
Generic Name erlotinib hydrochloride (source: ndc)
Application Number ANDA214719 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (46708-566-30)
  • 90 TABLET, FILM COATED in 1 BOTTLE (46708-566-90)
source: ndc

Packages (2)

46708-566-30 30 TABLET, FILM COATED in 1 BOTTLE (46708-566-30) 46708-566-90 90 TABLET, FILM COATED in 1 BOTTLE (46708-566-90)

Ingredients (1)

erlotinib hydrochloride (100 mg/1)

Linked Drug Pages (1)

ERLOTINIB HYDROCHLORIDE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "966e67f7-6259-4b1c-8c6a-b2589d57e1ed", "openfda": {"upc": ["0346708567309", "0346708566302", "0346708565305"], "unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["ab6f3cb3-34a8-4492-a5d7-fb6b055a2d6b"], "manufacturer_name": ["Alembic Pharmaceuticals Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (46708-566-30)", "package_ndc": "46708-566-30", "marketing_start_date": "20210709"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (46708-566-90)", "package_ndc": "46708-566-90", "marketing_start_date": "20210709"}], "brand_name": "ERLOTINIB HYDROCHLORIDE", "product_id": "46708-566_966e67f7-6259-4b1c-8c6a-b2589d57e1ed", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "46708-566", "generic_name": "ERLOTINIB HYDROCHLORIDE", "labeler_name": "Alembic Pharmaceuticals Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERLOTINIB HYDROCHLORIDE", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214719", "marketing_category": "ANDA", "marketing_start_date": "20210709", "listing_expiration_date": "20261231"}