Prescription drug · ANDA
Sodium Chloride NDC 63323-095
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 |
|---|---|---|---|
| 63323-095-61 | 63323009561 | 20 VIAL, PLASTIC in 1 TRAY (63323-095-61) / 100 mL in 1 VIAL, PLASTIC (63323-095-02)Marketed from Feb 14, 2022 |
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 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 63323-095_5db02ff9-4936-46b0-8fb5-3fc491895ae1SPL ID 5db02ff9-4936-46b0-8fb5-3fc491895ae1SPL set ID 8b44bfd3-70a4-4b47-bc7b-590f63b8cc75RxCUI 313016UNII 451W47IQ8XUPC 0363323095024
- 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
N463323009561followed by a unit qualifier and the quantityPackage 63323-0095-61. 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 23.4% Sodium Chloride Injection, USP is indicated for use as an electrolyte replenisher in parenteral fluid therapy. It serves as an additive for total parenteral nutrition (TPN) and as an additive for carbohydrate containing I.V. fluids.
Excerpt only. Read the full label for complete information.
About NDC 63323-095
- What is NDC 63323-095?
- 63323-095 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?
- 119 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 | 65219-504 | 65219-0504-20 |
| 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 | 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 tablet | Sodium chloride 1000 mg/1 | TabletOral | Belleview Bioscience LLC | 84447-002 | 84447-0002-01 |
| Sodium Chloridesodium chloride tablets | Sodium chloride 1000 mg/1 | TabletOral | Kesin Pharma Corporation | 81033-028 | 81033-0028-01 |
| Sodium Chloride | Sodium chloride 900 mg/100mL | IrrigantIrrigation | Baxter Healthcare Company | 0338-9834 | 00338-9834-04 |
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 2.5 meq/mL | Injection, Solution, ConcentrateIntravenous | Fresenius Kabi USA, LLC | 63323-090 |