erlotinib hydrochloride

Generic: erlotinib hydrochloride

Labeler: novadoz pharmaceuticals llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

erlotinib hydrochloride 100 mg/1

Manufacturer
Novadoz Pharmaceuticals LLC

Identifiers & Regulatory

Product NDC 72205-081
Product ID 72205-081_4cff04f5-3693-4d87-a9f8-a2b195e3d26e
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA214366
Listing Expiration 2026-12-31
Marketing Start 2021-05-11

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72205081
Hyphenated Format 72205-081

Supplemental Identifiers

RxCUI
603203 603206 603208
UPC
0372205081307 0372205082304 0372205080300
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 ANDA214366 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 100 mg/1
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (72205-081-30) / 30 TABLET, FILM COATED in 1 BOTTLE
source: ndc

Packages (1)

72205-081-30 1 BOTTLE in 1 CARTON (72205-081-30) / 30 TABLET, FILM COATED in 1 BOTTLE

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": "4cff04f5-3693-4d87-a9f8-a2b195e3d26e", "openfda": {"upc": ["0372205081307", "0372205082304", "0372205080300"], "unii": ["DA87705X9K"], "rxcui": ["603203", "603206", "603208"], "spl_set_id": ["4cff04f5-3693-4d87-a9f8-a2b195e3d26e"], "manufacturer_name": ["Novadoz Pharmaceuticals LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (72205-081-30)  / 30 TABLET, FILM COATED in 1 BOTTLE", "package_ndc": "72205-081-30", "marketing_start_date": "20210511"}], "brand_name": "Erlotinib Hydrochloride", "product_id": "72205-081_4cff04f5-3693-4d87-a9f8-a2b195e3d26e", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Kinase Inhibitor [EPC]", "Protein Kinase Inhibitors [MoA]"], "product_ndc": "72205-081", "generic_name": "Erlotinib Hydrochloride", "labeler_name": "Novadoz Pharmaceuticals LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Erlotinib Hydrochloride", "active_ingredients": [{"name": "ERLOTINIB HYDROCHLORIDE", "strength": "100 mg/1"}], "application_number": "ANDA214366", "marketing_category": "ANDA", "marketing_start_date": "20210511", "listing_expiration_date": "20261231"}