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United States · US · US:0088-2102_83c11919-ca6d-49f5-8f9f-7b8405fcbaec

Priftin

In shortageOrange BookUNIISPLATC J04AB05

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

Identification

Manufacturersanofi-aventis U.S. LLC
CountryUS (United States)
ATC codeJ04AB05
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0088210224
    3 BLISTER PACK in 1 CARTON (0088-2102-24) / 8 TABLET, FILM COATED in 1 BLISTER PACK (0088-2102-01)

Annotations

UNII (FDA Substance ID)
XJM390A33U
RIFAPENTINE
RxCUI 35617
Orange Book
N021024
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Rifapentine Tablet, Film Coated
Raw payload (JSON)
{
  "unii": {
    "unii": "XJM390A33U",
    "rxcui": "35617",
    "inchikey": "WDZCUPBHRAEYDL-GZAUEHORSA-N",
    "display_name": "RIFAPENTINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "3a64fb70-b85e-43d9-8bcd-7e893f568ae1": {
      "match": "brand_token",
      "title": "PRIFTIN (RIFAPENTINE) TABLET, FILM COATED [SANOFI-AVENTIS U.S. LLC]",
      "spl_version": "14",
      "published_date": "2026-02-10"
    }
  },
  "productid": "0088-2102_83c11919-ca6d-49f5-8f9f-7b8405fcbaec",
  "productndc": "0088-2102",
  "dosage_form": "TABLET, FILM COATED",
  "orange_book": {
    "appl_no": "021024",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "150MG",
        "product_no": "001",
        "approval_date": "Jun 22, 1998"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "RIFAPENTINE",
  "shortage_reason": "Rifapentine Tablet, Film Coated",
  "shortage_status": "current",
  "proprietary_name": "Priftin",
  "active_ingred_unit": "mg/1",
  "application_number": "NDA021024",
  "marketing_category": "NDA",
  "nonproprietary_name": "rifapentine",
  "start_marketing_date": "20170208",
  "active_numerator_strength": "150"
}

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