72485-219 NDC - ERLOTINIB (ERLOTINIB HYDROCHLORIDE)

Drug Information

  • Product NDC: 72485-219
  • Proprietary Name: Erlotinib
  • Non Proprietary Name: Erlotinib hydrochloride
  • Active Ingredient(s): 150 mg/1 ERLOTINIB HYDROCHLORIDE
  • Administration Route(s): ORAL
  • Dosage Form(s): TABLET, FILM COATED
  • Pharmacy Class(es): Kinase Inhibitor [EPC]; Protein Kinase Inhibitors [MoA]

Labeler Information

Field Name Field Value
Labeler Name: Armas Pharmaceuticals Inc.
Product Type: HUMAN PRESCRIPTION DRUG
FDA Application Number: ANDA211960
Marketing Category: ANDA
Start Marketing Date:11/6/2019

Package Information

No. Package Code Package Description Billing Unit
172485-219-301 BOTTLE in 1 BOX (72485-219-30) / 30 TABLET, FILM COATED in 1 BOTTLEEA

NDC Record

Field Name Field Value Definition
PRODUCT NDC72485-219The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
PRODUCT TYPE NAMEHUMAN PRESCRIPTION DRUGIndicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
PROPRIETARY NAMEErlotinibThe proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
NON PROPRIETARY NAMEErlotinib hydrochlorideThe non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
DOSAGE FORM NAMETABLET, FILM COATEDThe labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC.
ROUTE NAMEORALThe translation of the route code submitted by the firm, indicating route of administration.
START MARKETING DATE11/6/2019The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
MARKETING CATEGORY NAMEANDAA suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard.
APPLICATION NUMBERANDA211960The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
LABELER NAMEArmas Pharmaceuticals Inc.The translation of the dosage form Code submitted by the firm.
SUBSTANCE NAMEERLOTINIB HYDROCHLORIDEThe translation of the route code submitted by the firm, indicating route of administration.
ACTIVE NUMERATOR STRENGTH150 
ACTIVE INGRED UNITmg/1 
PHARM CLASSESKinase Inhibitor [EPC], Protein Kinase Inhibitors [MoA] 

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This page was last updated on: 12/6/2025

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