Prescription drug · NDA
Normosol-R and Dextrose NDC 0990-7968
Dextrose monohydrate 5 g/100mL + 5 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-7968-09 | 00990796809 | 12 BAG in 1 CASE (0990-7968-09) / 1000 mL in 1 BAGMarketed from May 14, 2020 |
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-R and Dextrose
- Generic name (nonproprietary)
- dextrose, sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride
- Active ingredients
- Dextrose monohydrate — 5 g/100mLSodium chloride — 526 mg/100mLSodium acetate anhydrous — 222 mg/100mLSodium gluconate — 502 mg/100mLPotassium chloride — 37 mg/100mLMagnesium chloride — 30 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 017609
- 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)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 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)Osmotic Activity (Mechanism)Osmotic Activity (Mechanism)Potassium Compounds (Chemical structure)Stimulation Large Intestine Fluid/Electrolyte Secretion (Physiologic effect)
- Identifiers
- Product ID 0990-7968_5a9ea0cc-bc33-45e5-b9ef-8893818e7803SPL ID 5a9ea0cc-bc33-45e5-b9ef-8893818e7803SPL set ID ead1fca3-eff4-478f-8a8f-67510f80151aRxCUI 801024, 1189629UNII LX22YL083G, 451W47IQ8X, NVG71ZZ7P0, R6Q3791S76, 660YQ98I10, 02F3473H9O
- 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
N400990796809followed by a unit qualifier and the quantityPackage 00990-7968-09. 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-R and 5% Dextrose Injection is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R and 5% Dextrose also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. The solution is not intended to supplant transfusion of whole blood or packed red cells in the presence of uncontrolled hemorrhage or severe reductions of red cell volume.
Excerpt only. Read the full label for complete information.
About NDC 0990-7968
- What is NDC 0990-7968?
- 0990-7968 is the product NDC for Normosol-R and Dextrose, Dextrose monohydrate 5 g/100mL + 5 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-R and Dextrose (Dextrose, Sodium Chloride, Sodium Acetate Anhydrous, Sodium Gluconate, Potassium Chloride, and Magnesium Chloride).
- What is the active ingredient?
- Dextrose monohydrate, Sodium chloride, Sodium acetate anhydrous, Sodium gluconate, Potassium chloride, Magnesium chloride.
- 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-R 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.