Prescription drug · ANDA
Sodium Chloride NDC 65282-1510
Sodium chloride 9 mg/mL · Injection, Solution · Intramuscular, Intravenous, Subcutaneous · Spectra Medical Deviecs, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65282-1510-1 | 65282151001 | 5 TRAY in 1 CARTON (65282-1510-1) / 5 AMPULE in 1 TRAY / 10 mL in 1 AMPULEMarketed from Jul 21, 2017 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 9 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous, Subcutaneous
- Labeler
- Spectra Medical Deviecs, LLCNDC labeler code 65282
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 206171
- Marketing start
- Listing expires
- Identifiers
- Product ID 65282-1510_447bf261-1a3a-2da1-e063-6394a90a7537SPL ID 447bf261-1a3a-2da1-e063-6394a90a7537SPL set ID 7e316d21-d6ad-4976-bd90-268fd7e51361RxCUI 1807637, 1807646UNII 451W47IQ8X
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
N465282151001followed by a unit qualifier and the quantityPackage 65282-1510-01. 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)
INDICATION AND USAGE This parenteral preparation is indicated only for diluting or dissolving drugs for intravenous, intramuscular or subcutaneous injection, according to instructions of the manufacturer of the drug to be administered.
Excerpt only. Read the full label for complete information.
About NDC 65282-1510
- What is NDC 65282-1510?
- 65282-1510 is the product NDC for Sodium Chloride, Sodium chloride 9 mg/mL injection, solution, listed with the FDA by Spectra Medical Deviecs, 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?
- Spectra Medical Deviecs, LLC, NDC labeler code 65282. 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 206171
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 9 mg/mL | Injection, SolutionIntramuscular, Intravenous, Subcutaneous | Spectra Medical Deviecs, LLC | 65282-1505 |