erlotinib

Generic: erlotinib

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

Drug Facts

Product Profile

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

erlotinib hydrochloride 25 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-263
Product ID 31722-263_1bca3db4-f885-5bed-e063-6294a90ae9fa
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209267
Listing Expiration 2026-12-31
Marketing Start 2024-05-24

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722263
Hyphenated Format 31722-263

Supplemental Identifiers

RxCUI
603203 603206 603208
UPC
0331722264303 0331722265300 0331722263306
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 ANDA209267 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 25 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (31722-263-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

31722-263-30 1 BOTTLE in 1 CARTON (31722-263-30) / 30 TABLET, FILM COATED in 1 BOTTLE

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": "1bca3db4-f885-5bed-e063-6294a90ae9fa", "openfda": {"upc": ["0331722264303", "0331722265300", "0331722263306"], "unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["a3b2d622-b4d5-4819-862b-f8fd3adcec6f"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (31722-263-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "31722-263-30", "marketing_start_date": "20240524"}], "brand_name": "ERLOTINIB", "product_id": "31722-263_1bca3db4-f885-5bed-e063-6294a90ae9fa", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "31722-263", "generic_name": "ERLOTINIB", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ERLOTINIB", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "25 mg/1"}], "application_number": "ANDA209267", "marketing_category": "ANDA", "marketing_start_date": "20240524", "listing_expiration_date": "20261231"}