Prescription drug · ANDA
Sodium Chloride NDC 63323-099
Sodium chloride 4 meq/mL · Injection, Solution, Concentrate · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63323-099-63 | 63323009963 | 10 VIAL, PLASTIC in 1 TRAY (63323-099-63) / 200 mL in 1 VIAL, PLASTIC (63323-099-03)Marketed from Jul 11, 2023 |
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 — 4 meq/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 63323
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 217796
- 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 63323-099_f5197532-af45-42c9-919b-30d00276650eSPL ID f5197532-af45-42c9-919b-30d00276650eSPL set ID b6e33138-841a-471f-a934-c4086cbc23f6RxCUI 313016UNII 451W47IQ8XUPC 0363323099039
- 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
N463323009963followed by a unit qualifier and the quantityPackage 63323-0099-63. 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: Sodium Chloride Injection, USP, 23.4%, is indicated as an additive in parenteral fluid therapy for use in patients who have special problems of sodium electrolyte intake or excretion. It is intended to meet the specific requirements of the patient with unusual fluid and electrolyte needs. After available clinical and laboratory information is considered and correlated, the appropriate number of milliequivalents of sodium chloride required can be withdrawn from Sodium Chloride Injection, USP, 23.4% and diluted for use. Sodium Chloride Injection is indicated for the treatment of sodium, chloride and water deficiencies that commonly occur in many diseases. Isotonic Sodium…
Excerpt only. Read the full label for complete information.
About NDC 63323-099
- What is NDC 63323-099?
- 63323-099 is the product NDC for Sodium Chloride, Sodium chloride 4 meq/mL injection, solution, concentrate, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Chloride.
- What is the active ingredient?
- Sodium chloride.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 63323. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Chloride?
- 116 other product NDCs are listed under this name. See all Sodium Chloride NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Chloride products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Chloride | Sodium chloride 50 mg/g | OintmentOphthalmic | YYBA CORP | 73581-707 | 73581-0707-0173581-0707-03 |
| Sodium Chloride | Sodium chloride 1 g/1 | TabletOral | Method Pharmaceuticals, LLC | 58657-119 | 58657-0119-01 |
| Sodium chloride | Sodium chloride .9 g/100mL | Injection, SolutionIrrigation | Fresenius Kabi USA, LLC | 65219-502 | 65219-0502-10 |
| Sodium chloride | Sodium chloride .9 g/100mL | Injection, SolutionIrrigation | Fresenius Kabi USA, LLC | 65219-504 | 65219-0504-20 |
| Sodium chloride | Sodium chloride .9 g/100mL | Injection, SolutionIrrigation | Becton Dickinson and Company | 17271-800 | 17271-0800-0717271-0800-0817271-0800-09 |
| Sodium Chloride | Sodium chloride 1000 mg/1 | TabletOral | Rising Pharma Holdings, Inc. | 57237-361 | 57237-0361-01 |
| Sodium chloride | Sodium chloride .9 g/100mL | Injection, SolutionIrrigation | Fresenius Kabi USA, LLC | 65219-506 | 65219-0506-30 |
| Sodium Chloridesodium chloride tablets | Sodium chloride 1000 mg/1 | TabletOral | Kesin Pharma Corporation | 81033-028 | 81033-0028-01 |
| Sodium Chloridesodium chloride tablet | Sodium chloride 1000 mg/1 | TabletOral | Belleview Bioscience LLC | 84447-002 | 84447-0002-01 |
| Sodium Chloride | Sodium chloride 900 mg/100mL | IrrigantIrrigation | Baxter Healthcare Company | 0338-9834 | 00338-9834-04 |