Prescription drug · ANDA
Sodium Chloride NDC 46163-300
Sodium chloride 900 mg/100mL · Injection · Intravenous · Fresenius Medical Care de Mexico, S.A. de C.V.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 46163-300-10 | 46163030010 | 12 BAG in 1 CARTON (46163-300-10) / 1000 mL in 1 BAGMarketed from Apr 12, 2007 |
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 — 900 mg/100mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Fresenius Medical Care de Mexico, S.A. de C.V.NDC labeler code 46163
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078177
- 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 46163-300_579dced3-07fc-680f-e063-6394a90a90ddSPL ID 579dced3-07fc-680f-e063-6394a90a90ddSPL set ID 9a1220fb-6853-45ae-838c-10d8596e1af7RxCUI 1807639UNII 451W47IQ8X
- 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
N446163030010followed by a unit qualifier and the quantityPackage 46163-0300-10. 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 Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient.
Excerpt only. Read the full label for complete information.
About NDC 46163-300
- What is NDC 46163-300?
- 46163-300 is the product NDC for Sodium Chloride, Sodium chloride 900 mg/100mL injection, listed with the FDA by Fresenius Medical Care de Mexico, S.A. de C.V.. 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 Medical Care de Mexico, S.A. de C.V., NDC labeler code 46163. 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 |
Other NDCs under ANDA 078177
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 900 mg/100mL | InjectionIntravenous | Fresenius Medical Care Renal Therapies Group, LLC | 49230-300 |