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United States · US · US:55792-007_4a638cd1-6922-477a-aa17-a70865ae0bd8

Elliotts B

Orange BookUNIISPLATC B05CX

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

Identification

ManufacturerLukare Medical, LLC
CountryUS (United States)
ATC codeB05CX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5579200710
    10 AMPULE in 1 BOX (55792-007-10) / 10 mL in 1 AMPULE (55792-007-01)

Annotations

UNII (FDA Substance ID)
5SL0G7R0OK
ANHYDROUS DEXTROSE
RxCUI 349730
Orange Book
N020577
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "5SL0G7R0OK",
    "rxcui": "349730",
    "inchikey": "GZCGUPFRVQAUEE-SLPGGIOYSA-N",
    "display_name": "ANHYDROUS DEXTROSE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRATHECAL",
  "spl_meta": {
    "08036dbd-55b3-47b9-9890-000f253544f3": {
      "match": "brand_token",
      "title": "ELLIOTTS B (SODIUM CATION, SODIUM BICARBONATE, ANHYDROUS DEXTROSE, MAGNESIUM SULFATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE, SODIUM PHOSPHATE) INJECTION [LUKARE MEDICAL, LLC]",
      "spl_version": "6",
      "published_date": "2024-10-18"
    }
  },
  "productid": "55792-007_4a638cd1-6922-477a-aa17-a70865ae0bd8",
  "productndc": "55792-007",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "020577",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9MG/ML;7.3MG/ML;0.2MG/ML",
        "product_no": "001",
        "approval_date": "Sep 27, 1996"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "ANHYDROUS DEXTROSE; CALCIUM CHLORIDE; MAGNESIUM SULFATE, UNSPECIFIED FORM; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE",
  "proprietary_name": "Elliotts B",
  "active_ingred_unit": "mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL",
  "application_number": "NDA020577",
  "marketing_category": "NDA",
  "nonproprietary_name": "sodium cation, sodium bicarbonate, anhydrous dextrose, magnesium sulfate, potassium chloride, calcium chloride, sodium phosphate",
  "start_marketing_date": "20130604",
  "active_numerator_strength": "8; 2; 3; 3; 19; 73; 2"
}

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