Prescription drug · NDA
Sodium Chloride NDC 0338-0048
Sodium chloride 900 mg/100mL · Irrigant · Irrigation · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0048-02 | 00338004802 | 24 BOTTLE, PLASTIC in 1 CARTON (0338-0048-02) / 250 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 | |
| 0338-0048-03 | 00338004803 | 18 BOTTLE, PLASTIC in 1 CARTON (0338-0048-03) / 500 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 | |
| 0338-0048-04 | 00338004804 | 12 BOTTLE, PLASTIC in 1 CARTON (0338-0048-04) / 1000 mL in 1 BOTTLE, PLASTICMarketed from Dec 31, 1974 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Irrigant
- Route
- Irrigation
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017427
- 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 0338-0048_1fe43459-21c4-4243-81bf-9674c1428f1eSPL ID 1fe43459-21c4-4243-81bf-9674c1428f1eSPL set ID b3b4b176-41f0-4ca8-90d4-3fba5707564aRxCUI 486515UNII 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.
- NDC on a medical claim
N400338004802followed by a unit qualifier and the quantityPackage 00338-0048-02. 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 Isotonic solution for irrigation only. Not for injection.
Excerpt only. Read the full label for complete information.
About NDC 0338-0048
- What is NDC 0338-0048?
- 0338-0048 is the product NDC for Sodium Chloride, Sodium chloride 900 mg/100mL irrigant, listed with the FDA by Baxter Healthcare Corporation. It has 3 package NDCs, 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?
- Baxter Healthcare Corporation, NDC labeler code 0338. 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 |