EXTRANEAL

In shortageOrange BookUNIISPL

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

Identification

ManufacturerVantive US Healthcare LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 4

ndc11
0941067905
2500 mL in 1 BAG (0941-0679-05)
ndc11
0941067906
2000 mL in 1 BAG (0941-0679-06)
ndc11
0941067952
2000 mL in 1 BAG (0941-0679-52)
ndc11
0941067953
2500 mL in 1 BAG (0941-0679-53)

Annotations

UNII (FDA Substance ID)

M4I0D6VV5M

CALCIUM CHLORIDE

RxCUI 221068

Orange Book

N021321

DailyMed SPL labels

1 version tracked

FDA shortage

Currently in shortage

Calcium Chloride Injection

Raw payload (JSON)

{
  "unii": {
    "unii": "M4I0D6VV5M",
    "rxcui": "221068",
    "inchikey": "LLSDKQJKOVVTOJ-UHFFFAOYSA-L",
    "display_name": "CALCIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAPERITONEAL",
  "spl_meta": {
    "d5b85158-b0d6-4855-9d07-8d1b3ad9ab71": {
      "match": "brand_token",
      "title": "EXTRANEAL (ICODEXTRIN, SODIUM CHLORIDE, SODIUM LACTATE, CALCIUM CHLORIDE, MAGNESIUM CHLORIDE) INJECTION, SOLUTION [VANTIVE US HEALTHCARE LLC]",
      "spl_version": "24",
      "published_date": "2025-12-10"
    }
  },
  "productid": "0941-0679_8412c95a-1cc2-4ae7-baf9-3dc30d5b93a1",
  "productndc": "0941-0679",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "021321",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "7.5GM/100ML",
        "product_no": "001",
        "approval_date": "Dec 20, 2002"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIUM CHLORIDE; ICODEXTRIN; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE",
  "shortage_reason": "Calcium Chloride Injection",
  "shortage_status": "current",
  "proprietary_name": "EXTRANEAL",
  "active_ingred_unit": "mg/100mL; g/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA021321",
  "marketing_category": "NDA",
  "nonproprietary_name": "icodextrin, sodium chloride, sodium lactate, calcium chloride, magnesium chloride",
  "start_marketing_date": "20021220",
  "active_numerator_strength": "25.7; 7.5; 5.08; 535; 448"
}

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