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United States · US · US:0990-7926_391a9854-64db-4da4-b8a5-a230001aa81c

Dextrose and Sodium Chloride

In shortageOrange BookUNIISPL

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

Identification

ManufacturerICU Medical Inc.
CountryUS (United States)
ATC code
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    0990792602
    24 POUCH in 1 CASE (0990-7926-02) / 1 BAG in 1 POUCH / 250 mL in 1 BAG
  • ndc11
    0990792603
    24 POUCH in 1 CASE (0990-7926-03) / 1 BAG in 1 POUCH / 500 mL in 1 BAG
  • ndc11
    0990792609
    12 POUCH in 1 CASE (0990-7926-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Annotations

UNII (FDA Substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N017607
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 50% Injection
Raw payload (JSON)
{
  "unii": {
    "unii": "LX22YL083G",
    "rxcui": "1299920",
    "inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
    "display_name": "DEXTROSE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "60b6d7c3-0164-46c9-aa38-b5aa1c31a5d5": {
      "match": "brand_token",
      "title": "DEXTROSE INJECTION, SOLUTION [B. BRAUN MEDICAL INC.]",
      "spl_version": "11",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0990-7926_391a9854-64db-4da4-b8a5-a230001aa81c",
  "productndc": "0990-7926",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017607",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": "AP",
        "strength": "5GM/100ML;450MG/100ML",
        "product_no": "001",
        "approval_date": "Approved Prior to Jan 1, 1982"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXTROSE MONOHYDRATE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 50% Injection",
  "shortage_status": "current",
  "proprietary_name": "Dextrose and Sodium Chloride",
  "active_ingred_unit": "g/100mL; g/100mL",
  "application_number": "NDA017607",
  "marketing_category": "NDA",
  "nonproprietary_name": "DEXTROSE MONOHYDRATE and SODIUM CHLORIDE",
  "start_marketing_date": "20190901",
  "active_numerator_strength": "5; .45"
}

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