Prescription drug · ANDA
Sodium Chloride NDC 63323-090
Sodium chloride 2.5 meq/mL · Injection, Solution, Concentrate · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-090-20 | 63323009020 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-20) / 20 mL in 1 VIAL, PLASTIC (63323-090-02)Marketed from Apr 28, 2021 | |
| 63323-090-40 | 63323009040 | 25 VIAL, PLASTIC in 1 TRAY (63323-090-40) / 40 mL in 1 VIAL, PLASTIC (63323-090-04)Marketed from Apr 28, 2021 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Sodium Chloride
- Generic name (nonproprietary)
- sodium chloride
- Active ingredients
- Sodium chloride — 2.5 meq/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212070
- Marketing start
- Listing expires
- Other FDA classes
- Increased Large Intestinal Motility (Physiologic effect)Inhibition Large Intestine Fluid/Electrolyte Absorption (Physiologic effect)Osmotic Activity (Mechanism)
- Identifiers
- Product ID 63323-090_eb8f5fdb-b8da-4d67-a5e0-b2479bf38170SPL ID eb8f5fdb-b8da-4d67-a5e0-b2479bf38170SPL set ID ed8fd0c1-ac42-4267-877e-ceadf3831c90RxCUI 1807578, 1807580UNII 451W47IQ8XUPC 0363323090043
- Pharmacologic class
- Osmotic Laxative
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
N463323009020followed by a unit qualifier and the quantityPackage 63323-0090-20. 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 14.6% Sodium Chloride Injection, USP Additive Solution is indicated for parenteral restoration of sodium ion in patients with restricted oral intake. Sodium replacement is specifically indicated in patients with hyponatremia or low salt syndrome. 14.6% Sodium Chloride Additive Solution may also be added to compatible carbohydrate solutions such as dextrose in water to provide electrolytes.
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212070
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 |
|---|---|---|---|---|
| Sodium Chloride | Sodium chloride 4 meq/mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 63323-095 |