ERLOTINIB

Orange BookUNIISPLATC L01EB02

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

Identification

ManufacturerCamber Pharmaceuticals, Inc.

CountryUS (United States)

ATC codeL01EB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
3172226330
1 BOTTLE in 1 CARTON (31722-263-30) / 30 TABLET, FILM COATED in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

DA87705X9K

ERLOTINIB HYDROCHLORIDE

RxCUI 477320

Orange Book

A209267

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": "31722-263_1bca3db4-f885-5bed-e063-6294a90ae9fa",
  "productndc": "31722-263",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "209267",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "May 24, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "May 24, 2024"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "May 24, 2024"
      }
    ],
    "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": "ANDA209267",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ERLOTINIB",
  "start_marketing_date": "20240524",
  "active_numerator_strength": "25"
}

Related drugs

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