ERLOTINIB HYDROCHLORIDE

Orange BookUNIISPLATC L01EB02

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

Identification

ManufacturerAlembic Pharmaceuticals Inc.

CountryUS (United States)

ATC codeL01EB02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 2

ndc11
6233256630
30 TABLET, FILM COATED in 1 BOTTLE (62332-566-30)
ndc11
6233256690
90 TABLET, FILM COATED in 1 BOTTLE (62332-566-90)

Annotations

UNII (FDA Substance ID)

DA87705X9K

ERLOTINIB HYDROCHLORIDE

RxCUI 477320

Orange Book

A214719

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": "62332-566_78cde6f1-5cd7-428e-8ae8-e707d4d5f484",
  "productndc": "62332-566",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "214719",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 25MG BASE",
        "product_no": "001",
        "approval_date": "Jul 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 100MG BASE",
        "product_no": "002",
        "approval_date": "Jul 8, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "EQ 150MG BASE",
        "product_no": "003",
        "approval_date": "Jul 8, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ERLOTINIB HYDROCHLORIDE",
  "proprietary_name": "ERLOTINIB HYDROCHLORIDE",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA214719",
  "marketing_category": "ANDA",
  "nonproprietary_name": "ERLOTINIB HYDROCHLORIDE",
  "start_marketing_date": "20210709",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code L01EB02.

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