United States· US:0990-7670_59eb85f7-9d0b-4b22-bc56-c655f9615d8c

Normosol-R

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

ATC 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-RATCC03CBREGISTER NO.US:0990-7670_59eb85f7…PACKS LISTED2CHECKEDJune 3, 2026

The record

At a glance

FDA National Drug Code directory (United States)
Active substance
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE
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 · 2

  • ndc11
    0990767003
    24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAG
  • ndc11
    0990767009
    12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAG

Regulatory notes

UNII (FDA substance ID)
02F3473H9O
MAGNESIUM CHLORIDE
RxCUI 221118
Orange Book
N017586
DailyMed SPL labels
1 version tracked

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/b152fb45-547b-4a07-82b8-5d0370ea870c
GET /v1/drugs/b152fb45-547b-4a07-82b8-5d0370ea870c?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": "02F3473H9O",
    "rxcui": "221118",
    "inchikey": "DHRRIBDTHFBPNG-UHFFFAOYSA-L",
    "display_name": "MAGNESIUM CHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "ead1fca3-eff4-478f-8a8f-67510f80151a": {
      "match": "brand_token",
      "title": "NORMOSOL-R AND DEXTROSE (DEXTROSE, SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) INJECTION, SOLUTION [ICU MEDICAL INC.]",
      "spl_version": "13",
      "published_date": "2025-11-17"
    }
  },
  "productid": "0990-7670_59eb85f7-9d0b-4b22-bc56-c655f9615d8c",
  "productndc": "0990-7670",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "017586",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/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": "MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM CHLORIDE; SODIUM GLUCONATE",
  "proprietary_name": "Normosol-R",
  "active_ingred_unit": "mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL",
  "application_number": "NDA017586",
  "marketing_category": "NDA",
  "nonproprietary_name": "SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE",
  "start_marketing_date": "20190901",
  "active_numerator_strength": "30; 37; 222; 526; 502"
}

See everything about sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride.

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.