Cleviprex

Orange BookUNIISPLATC C08CA16

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

Identification

ManufacturerChiesi USA, Inc.

CountryUS (United States)

ATC codeC08CA16

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
1012261010
10 CARTON in 1 CARTON (10122-610-10) / 1 VIAL, SINGLE-USE in 1 CARTON (10122-610-01) / 50 mL in 1 VIAL, SINGLE-USE

Annotations

UNII (FDA Substance ID)

19O2GP3B7Q

CLEVIDIPINE

RxCUI 977863

Orange Book

N022156

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "19O2GP3B7Q",
    "rxcui": "977863",
    "inchikey": "KPBZROQVTHLCDU-UHFFFAOYSA-N",
    "display_name": "CLEVIDIPINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "f9290625-b723-4eda-bab8-a97bef6041f6": {
      "match": "brand_token",
      "title": "CLEVIPREX (CLEVIPIDINE) EMULSION [CHIESI USA, INC.]",
      "spl_version": "26",
      "published_date": "2025-11-17"
    }
  },
  "productid": "10122-610_e472cde4-d29e-44b2-b1ca-a6f4fcc01b1d",
  "productndc": "10122-610",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "022156",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "25MG/50ML (0.5MG/ML)",
        "product_no": "001",
        "approval_date": "Aug 1, 2008"
      },
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "50MG/100ML (0.5MG/ML)",
        "product_no": "002",
        "approval_date": "Aug 1, 2008"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "125MG/250ML (0.5MG/ML)",
        "product_no": "003",
        "approval_date": "Nov 8, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLEVIDIPINE",
  "proprietary_name": "Cleviprex",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA022156",
  "marketing_category": "NDA",
  "nonproprietary_name": "clevipidine",
  "start_marketing_date": "20080915",
  "active_numerator_strength": ".5"
}

Related drugs

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