Pretomanid

Orange BookUNIISPLATC J04AK08

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

Identification

ManufacturerViatris Specialty LLC

CountryUS (United States)

ATC codeJ04AK08

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4950247626
1 BOTTLE in 1 CARTON (49502-476-26) / 26 TABLET in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

2XOI31YC4N

PRETOMANID

RxCUI 2198359

Orange Book

N212862

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "2XOI31YC4N",
    "rxcui": "2198359",
    "inchikey": "ZLHZLMOSPGACSZ-NSHDSACASA-N",
    "display_name": "PRETOMANID",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "f1906fc9-cb3c-4e13-8a4a-da76100c1bf3": {
      "match": "brand_token",
      "title": "PRETOMANID TABLET [VIATRIS SPECIALTY LLC]",
      "spl_version": "13",
      "published_date": "2025-04-10"
    }
  },
  "productid": "49502-476_99ba96bb-da73-4082-bb81-c573f6019013",
  "productndc": "49502-476",
  "dosage_form": "TABLET",
  "orange_book": {
    "appl_no": "212862",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "200MG",
        "product_no": "001",
        "approval_date": "Aug 14, 2019"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "PRETOMANID",
  "proprietary_name": "Pretomanid",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA212862",
  "marketing_category": "NDA",
  "nonproprietary_name": "Pretomanid",
  "start_marketing_date": "20191107",
  "active_numerator_strength": "200"
}

Related drugs

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