erlotinib

Generic: erlotinib

Labeler: sun pharmaceutical industries, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name erlotinib
Generic Name erlotinib
Labeler sun pharmaceutical industries, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

erlotinib 100 mg/1

Manufacturer
Sun Pharmaceutical Industries, Inc.

Identifiers & Regulatory

Product NDC 63304-096
Product ID 63304-096_c160713b-c06f-49b4-80ea-fc1afb030b81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA210300
Listing Expiration 2026-12-31
Marketing Start 2019-11-05

Pharmacologic Class

Established (EPC)
kinase inhibitor [epc]
Mechanism of Action
protein kinase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63304096
Hyphenated Format 63304-096

Supplemental Identifiers

RxCUI
603203 603206 603208
UPC
0363304095302
UNII
J4T82NDH7E
NUI
N0000175605 N0000175076

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 ANDA210300 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 3 BLISTER PACK in 1 CARTON (63304-096-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-096-31)
  • 30 TABLET, FILM COATED in 1 BOTTLE (63304-096-30)
source: ndc

Packages (2)

63304-096-11 3 BLISTER PACK in 1 CARTON (63304-096-11) / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-096-31) 63304-096-30 30 TABLET, FILM COATED in 1 BOTTLE (63304-096-30)

Ingredients (1)

erlotinib (100 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": "c160713b-c06f-49b4-80ea-fc1afb030b81", "openfda": {"nui": ["N0000175605", "N0000175076"], "upc": ["0363304095302"], "unii": ["J4T82NDH7E"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["e36fa076-e23b-437f-bbd2-0433ce333175"], "pharm_class_epc": ["Kinase Inhibitor [EPC]"], "pharm_class_moa": ["Protein Kinase Inhibitors [MoA]"], "manufacturer_name": ["Sun Pharmaceutical Industries, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3 BLISTER PACK in 1 CARTON (63304-096-11)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (63304-096-31)", "package_ndc": "63304-096-11", "marketing_start_date": "20191105"}, {"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (63304-096-30)", "package_ndc": "63304-096-30", "marketing_start_date": "20191105"}], "brand_name": "Erlotinib", "product_id": "63304-096_c160713b-c06f-49b4-80ea-fc1afb030b81", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "63304-096", "generic_name": "Erlotinib", "labeler_name": "Sun Pharmaceutical Industries, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB", "strength": "100 mg/1"}], "application_number": "ANDA210300", "marketing_category": "ANDA", "marketing_start_date": "20191105", "listing_expiration_date": "20261231"}