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United States · US · US:70518-2966_4aba550b-837b-4af9-e063-6394a90af074

Ethambutol Hydrochloride

Orange BookUNIISPLATC J04AK02

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerREMEDYREPACK INC.
CountryUS (United States)
ATC codeJ04AK02
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7051829660
    30 TABLET in 1 BLISTER PACK (70518-2966-0)

Annotations

UNII (FDA Substance ID)
QE4VW5FO07
ETHAMBUTOL HYDROCHLORIDE
RxCUI 142435
Orange Book
A078939
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": "70518-2966_4aba550b-837b-4af9-e063-6394a90af074",
  "productndc": "70518-2966",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "078939",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "100MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2009"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "400MG",
        "product_no": "002",
        "approval_date": "Jun 17, 2009"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ETHAMBUTOL HYDROCHLORIDE",
  "proprietary_name": "Ethambutol Hydrochloride",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA078939",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Ethambutol Hydrochloride",
  "start_marketing_date": "20201211",
  "active_numerator_strength": "400"
}

Related drugs

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