erlotinib

Generic: erlotinib

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

Drug Facts

Product Profile

Brand Name erlotinib
Generic Name erlotinib
Labeler zydus pharmaceuticals usa inc.
Dosage Form TABLET
Routes
ORAL
Active Ingredients

erlotinib hydrochloride 100 mg/1

Manufacturer
Zydus Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 68382-914
Product ID 68382-914_e34fafdf-2fda-4031-9202-6d7e85925dc1
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 68382914
Hyphenated Format 68382-914

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
  • 100 mg/1
source: ndc
Packaging
  • 30 TABLET in 1 BOTTLE (68382-914-06)
  • 90 TABLET in 1 BOTTLE (68382-914-16)
  • 3 BLISTER PACK in 1 CARTON (68382-914-84) / 10 TABLET in 1 BLISTER PACK (68382-914-30)
source: ndc

Packages (3)

68382-914-06 30 TABLET in 1 BOTTLE (68382-914-06) 68382-914-16 90 TABLET in 1 BOTTLE (68382-914-16) 68382-914-84 3 BLISTER PACK in 1 CARTON (68382-914-84) / 10 TABLET in 1 BLISTER PACK (68382-914-30)

Ingredients (1)

erlotinib hydrochloride (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": "e34fafdf-2fda-4031-9202-6d7e85925dc1", "openfda": {"unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["c35e019d-ec34-4e61-9400-a7ae7913e025"], "manufacturer_name": ["Zydus Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET in 1 BOTTLE (68382-914-06)", "package_ndc": "68382-914-06", "marketing_start_date": "20200430"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (68382-914-16)", "package_ndc": "68382-914-16", "marketing_start_date": "20200430"}, {"sample": false, "description": "3 BLISTER PACK in 1 CARTON (68382-914-84)  / 10 TABLET in 1 BLISTER PACK (68382-914-30)", "package_ndc": "68382-914-84", "marketing_start_date": "20200430"}], "brand_name": "Erlotinib", "product_id": "68382-914_e34fafdf-2fda-4031-9202-6d7e85925dc1", "dosage_form": "TABLET", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "68382-914", "generic_name": "Erlotinib", "labeler_name": "Zydus Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA213065", "marketing_category": "ANDA", "marketing_start_date": "20200430", "listing_expiration_date": "20261231"}