Prescription drug · NDA
Normosol-M And Dextrose NDC 0990-7965
dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate · Dextrose monohydrate 5 g/100mL + 3 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-7965-09 | 00990796509 | 12 POUCH in 1 CASE (0990-7965-09) / 1 BAG in 1 POUCH / 1000 mL in 1 BAGMarketed from Feb 8, 2021 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Normosol-M And Dextrose
- Generic name (nonproprietary)
- dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate
- Active ingredients
- Dextrose monohydrate — 5 g/100mLSodium chloride — 234 mg/100mLPotassium acetate — 128 mg/100mLMagnesium acetate — 21 mg/100mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- ICU Medical Inc.NDC labeler code 0990
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017610
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Inhibition Small Intestine Fluid/Electrolyte Absorption (Physiologic effect)Magnesium Ion Exchange Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0990-7965_4c144127-6bca-4067-8d7a-75859a8e2aa5SPL ID 4c144127-6bca-4067-8d7a-75859a8e2aa5SPL set ID aba60c84-94d9-46d0-bdbb-25e0c4e8cc41RxCUI 801005, 801009UNII LX22YL083G, 451W47IQ8X, M911911U02, 0E95JZY48K
- Pharmacologic class
- Calculi Dissolution Agent; Osmotic Laxative; Potassium Salt
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
- NDC on a medical claim
N400990796509followed by a unit qualifier and the quantityPackage 00990-7965-09. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
INDICATIONS AND USAGE Normosol-M and 5% Dextrose Injection (Multiple Electrolytes and 5% Dextrose Injection Type 1, USP) is indicated for parenteral maintenance of routine daily fluid and electrolyte requirements with minimal carbohydrate calories from dextrose. Magnesium in the formula may help to prevent iatrogenic magnesium deficiency in patients receiving prolonged parenteral therapy.
Excerpt only. Read the full label for complete information.
About NDC 0990-7965
- What is NDC 0990-7965?
- 0990-7965 is the product NDC for Normosol-M And Dextrose, Dextrose monohydrate 5 g/100mL + 3 more ingredients injection, solution, listed with the FDA by ICU Medical Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Normosol-M And Dextrose (Dextrose monohydrate, sodium chloride, potassium acetate, and magnesium acetate).
- What is the active ingredient?
- Dextrose monohydrate, Sodium chloride, Potassium acetate, Magnesium acetate.
- Who is the labeler?
- ICU Medical Inc., NDC labeler code 0990. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Normosol-M And Dextrose?
- None: this is the only finished product listed under this name.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.