Prescription drug · NDA
sodium bicarbonate NDC 0338-0822
Sodium bicarbonate 12.6 mg/mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0822-10 | 0033808221000338082210 | 10 BAG in 1 CARTON (0338-0822-10) / 1000 mL in 1 BAGMarketed from Aug 14, 2026 |
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 bicarbonate
- Generic name (nonproprietary)
- sodium bicarbonate
- Active ingredients
- Sodium bicarbonate — 12.6 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Baxter Healthcare CorporationNDC labeler code 0338
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 218524
- Marketing start
- Listing expires
- Other FDA classes
- Alkalinizing Activity (Mechanism)
- Identifiers
- Product ID 0338-0822_b50c858a-00c8-4cb2-ad73-8797f19e656dSPL ID b50c858a-00c8-4cb2-ad73-8797f19e656dSPL set ID b50c858a-00c8-4cb2-ad73-8797f19e656dRxCUI 2747138UNII 8MDF5V39QO
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
N400338082210followed by a unit qualifier and the quantityPackage 00338-0822-10. 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)
Sodium bicarbonate injection is an alkalinizing agent indicated: • to raise plasma pH in adult and pediatric patients with clinically significant metabolic acidosis. ( 1.1 ) • to alkalinize the urine in drug poisoning in adult and pediatric patients in cases in which urinary drug elimination is enhanced by urinary alkalinaztion. ( 1.2 ) Limitation of Use Do not use sodium bicarbonate injection in settings where rapid administration of sodium bicarbonate is required, such as cardiac arrest. In such situations use a more concentrated solution. 1.1 Treatment of Clinically Significant Metabolic Acidosis Sodium bicarbonate injection is indicated to raise plasma pH in adult and pediatric patients …
Excerpt only. Read the full label for complete information.
About NDC 0338-0822
- What is NDC 0338-0822?
- 0338-0822 is the product NDC for sodium bicarbonate, Sodium bicarbonate 12.6 mg/mL injection, solution, listed with the FDA by Baxter Healthcare Corporation. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- sodium bicarbonate.
- What is the active ingredient?
- Sodium bicarbonate.
- 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 bicarbonate?
- 55 other product NDCs are listed under this name. See all sodium bicarbonate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other sodium bicarbonate 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 Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Milla Pharmaceuticals Inc. | 71357-004 | 71357-0004-10 |
| Sodium Bicarbonate | Sodium bicarbonate 12.6 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2613 | 80830-2613-02 |
| Sodium Bicarbonatesodium bicarbonate, injection | Sodium bicarbonate 84 mg/mL | SolutionIntravenous | Civica, Inc. | 72572-200 | 72572-0200-20 |
| Sodium Bicarbonate | Sodium bicarbonate 2.6 g/2.6g | PowderOral | Vitamex USA, Corp | 69469-100 | 69469-0100-04 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Amneal Pharmaceuticals Private Limited | 80830-2305 | 80830-2305-02 |
| Sodium Bicarbonate | Sodium bicarbonate 42 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-083 | 63323-0083-05 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-089 | 63323-0089-50 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Glenmark Pharmaceuticals Inc., USA | 68462-951 | 68462-0951-65 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC. | 71872-7376 | 71872-7376-01 |
| Sodium Bicarbonate | Sodium bicarbonate 84 mg/mL | Injection, SolutionIntravenous | Anthea Pharma Private Limited | 83854-001 | 83854-0001-2083854-0001-25 |