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..
Checked against FDA National Drug Code directory (United States) on
Informational only — not a medical device.
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
- ndc11099079650912 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAG
Regulatory notes
Same class
Other records under C03CB
Sulfonamides and potassium in combination, as other registers publish it.
- United StatesColgate Sensitive Complete ProtectionColgate-Palmolive Company
- United StatesColgate Sensitive Enamel HealthColgate-Palmolive Company
- United StatesIonosol MB and DextroseICU Medical Inc.
- United StatesLactated RingersICU Medical Inc.
- United StatesLactated RingersICU Medical Inc.
- United StatesLactated Ringers and DextroseICU Medical Inc.
- United StatesLymph CareHealth and Harmony Products
- United StatesNormosol-RICU Medical Inc.
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.