Ethambutol Hydrochloride

Orange BookUNIISPLATC J04AK02

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

Identification

ManufacturerKanchan Healthcare Inc

CountryUS (United States)

ATC codeJ04AK02

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
8574200504
100 TABLET, FILM COATED in 1 BOTTLE (85742-005-04)

Annotations

UNII (FDA Substance ID)

QE4VW5FO07

ETHAMBUTOL HYDROCHLORIDE

RxCUI 142435

Orange Book

N016320

ABAB

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "QE4VW5FO07",
    "rxcui": "142435",
    "inchikey": "AUAHHJJRFHRVPV-BZDVOYDHSA-N",
    "display_name": "ETHAMBUTOL HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3f6428d6-3745-4337-ad78-ebfff9f49135": {
      "match": "brand_token",
      "title": "ETHAMBUTOL HYDROCHLORIDE TABLET, FILM COATED [STI PHARMA LLC]",
      "spl_version": "9",
      "published_date": "2026-05-07"
    }
  },
  "productid": "85742-005_2a57c753-d5e5-4479-845b-614c928d6dc5",
  "productndc": "85742-005",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "016320",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "200MG",
        "product_no": "002",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "003",
        "approval_date": "Approved Prior to Jan 1, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "500MG",
        "product_no": "004",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHAMBUTOL HYDROCHLORIDE",
  "proprietary_name": "Ethambutol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA016320",
  "marketing_category": "NDA AUTHORIZED GENERIC",
  "nonproprietary_name": "Ethambutol Hydrochloride",
  "start_marketing_date": "20061215",
  "active_numerator_strength": "100"
}

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