Erlotinib

Orange BookUNIISPLATC L01EB02

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeL01EB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0093766456
30 TABLET, FILM COATED in 1 BOTTLE (0093-7664-56)

Annotations

UNII (FDA Substance ID)

DA87705X9K

ERLOTINIB HYDROCHLORIDE

RxCUI 477320

Orange Book

A091059

ABABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "DA87705X9K",
    "rxcui": "477320",
    "inchikey": "GTTBEUCJPZQMDZ-UHFFFAOYSA-N",
    "display_name": "ERLOTINIB HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "daaa1329-3a3f-439c-b13d-b301daa234d4": {
      "match": "brand_token",
      "title": "ERLOTINIB TABLET, FILM COATED [ZYDUS LIFESCIENCES LIMITED]",
      "spl_version": "3",
      "published_date": "2024-12-02"
    }
  },
  "productid": "0093-7664_4368f7b2-5bdb-4232-90b0-f6a769d71e9b",
  "productndc": "0093-7664",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "091059",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Nov 9, 2020"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Aug 28, 2015"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Aug 28, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERLOTINIB HYDROCHLORIDE",
  "proprietary_name": "Erlotinib",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA091059",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Erlotinib",
  "start_marketing_date": "20190509",
  "active_numerator_strength": "150"
}

Related drugs

Other records sharing ATC code L01EB02.

Access this data programmatically

Query Erlotinib and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.

Get a free API key Read the API docs