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United States· US:0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc

NORMOSOL-M AND DEXTROSE

A sulfonamides and potassium in combination product containing dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate, registered in United States by ICU Medical Inc..

In shortageATC C03CBOrange BookUS label

Checked against FDA National Drug Code directory (United States) on

Informational only — not a medical device.

SOURCE REGISTER · USFDA National Drug Code directory (Unite…normalisedNORMOSOL-M AND DEXTROSEATCC03CBREGISTER NO.US:0990-7965_82c807c8…PACKS LISTED1CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
Manufacturer
ICU Medical Inc.
Country
United States (US)
ATC code
C03CB
ATC class
Sulfonamides and potassium in combination
Reimbursed
Not published by this register
Source register
FDA National Drug Code directory (United States)
Last checked
June 3, 2026

Packs & prices · 1

  • ndc11
    0990796509
    12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG

Regulatory notes

UNII (FDA substance ID)
LX22YL083G
DEXTROSE MONOHYDRATE
RxCUI 1299920
Orange Book
N017610
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Dextrose Monohydrate 10% Injection

Sourced from a public register and reproduced with attribution. Drug Database is not affiliated with, endorsed by, or a partner of FDA National Drug Code directory (United States). This is an informational data service and not a medical device — verify against the official source of record before any clinical decision.

For developers

The same record over the API, and the raw payload
GET /v1/drugs/4279b5e9-3bcd-4dde-9e4e-14f4dbfdd51c
GET /v1/drugs/4279b5e9-3bcd-4dde-9e4e-14f4dbfdd51c?format=fhir

Every response carries last_synced_at, so freshness is a field rather than a promise. Below is exactly what the ingestion wrote, before any presentation — the same JSON the API returns under payload.

{
  "unii": {
    "unii": "LX22YL083G",
    "rxcui": "1299920",
    "inchikey": "SPFMQWBKVUQXJV-BTVCFUMJSA-N",
    "display_name": "DEXTROSE MONOHYDRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "aba60c84-94d9-46d0-bdbb-25e0c4e8cc41": {
      "match": "brand_token",
      "title": "NORMOSOL-M AND DEXTROSE (DEXTROSE MONOHYDRATE, SODIUM CHLORIDE, POTASSIUM ACETATE, AND MAGNESIUM ACETATE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
      "spl_version": "11",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0990-7965_82c807c8-da31-4166-803f-a194b26dd1dc",
  "productndc": "0990-7965",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017610",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "5GM/100ML;21MG/100ML;128MG/100ML;234MG/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; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE",
  "shortage_reason": "Dextrose Monohydrate 10% Injection",
  "shortage_status": "current",
  "proprietary_name": "NORMOSOL-M AND DEXTROSE",
  "active_ingred_unit": "g/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA017610",
  "marketing_category": "NDA",
  "nonproprietary_name": "dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate",
  "start_marketing_date": "20210208",
  "active_numerator_strength": "5; 21; 128; 234"
}

See everything about dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate.

This page is the registration. A free account adds the label text as the regulator wrote it, what it costs per daily dose across the markets that publish a price, a feed of what changes in the registers, and an assistant that answers with its sources. Interaction severity is free; mechanism and management are on the Growth plan. No card, nothing to install.