Prescription drug · NDA
Normosol-R NDC 0990-7670
Sodium chloride 526 mg/100mL + 4 more ingredients · Injection, Solution · Intravenous · ICU Medical Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0990-7670-03 | 00990767003 | 24 BAG in 1 CASE (0990-7670-03) / 500 mL in 1 BAGMarketed from Dec 31, 2019 | |
| 0990-7670-09 | 00990767009 | 12 BAG in 1 CASE (0990-7670-09) / 1000 mL in 1 BAGMarketed from Sep 1, 2019 |
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
- Generic name (nonproprietary)
- sodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride
- Active ingredients
- Sodium 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 017586
- 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 0990-7670_ef046fec-fc50-46b1-89a2-f35ddb2d482cSPL ID ef046fec-fc50-46b1-89a2-f35ddb2d482cSPL set ID 0e089a44-0cee-4804-8f6f-8508508ddb5cRxCUI 800985, 800988UNII 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
N400990767003followed by a unit qualifier and the quantityPackage 00990-7670-03. 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 pH 7.4 is indicated for replacement of acute extracellular fluid volume losses in surgery, trauma, burns or shock. Normosol-R pH 7.4 also can be used as an adjunct to restore a decrease in circulatory volume in patients with moderate blood loss. Normosol-R pH 7.4 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. Normosol-R pH 7.4 is particularly valuable as a solution for use in starting blood, i.e., as a priming solution for the infusion set. No hemolysis of blood is seen at the interface or with mixed solution and blood. It may also be used as a dilu…
Excerpt only. Read the full label for complete information.
About NDC 0990-7670
- What is NDC 0990-7670?
- 0990-7670 is the product NDC for Normosol-R, Sodium chloride 526 mg/100mL + 4 more ingredients injection, solution, listed with the FDA by ICU Medical Inc.. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Normosol-R (Sodium chloride, Sodium acetate anhydrous, Sodium gluconate, Potassium chloride, And magnesium chloride).
- What is the active ingredient?
- 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?
- 1 other product NDC are listed under this name. See all Normosol-R NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Normosol-R products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Normosol-Rsodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride | Sodium chloride 526 mg/100mL + 4 more ingredients | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7967 | 00990-7967-09 |
Other NDCs under NDA 017586
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Normosol-Rsodium chloride, sodium acetate anhydrous, sodium gluconate, potassium chloride, and magnesium chloride | Sodium chloride 526 mg/100mL + 4 more ingredients | Injection, SolutionIntravenous | ICU Medical Inc. | 0990-7967 |