Prescription drug · NDA
Norepinephrine Bitartrate NDC 0338-0128
Norepinephrine bitartrate 16 mg/250mL · Injection, Solution · Intravenous · Baxter Healthcare Corporation
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0338-0128-20 | 00338012820 | 20 BAG in 1 CARTON (0338-0128-20) / 250 mL in 1 BAGMarketed from Feb 6, 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)
- Norepinephrine Bitartrate
- Generic name (nonproprietary)
- norepinephrine bitartrate
- Active ingredients
- Norepinephrine bitartrate — 16 mg/250mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 214313
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)
- Identifiers
- Product ID 0338-0128_b40627c0-67bf-4740-9d21-83054aa6afd9SPL ID b40627c0-67bf-4740-9d21-83054aa6afd9SPL set ID 6363e9b4-29df-4553-904d-a563e5adda6eRxCUI 2475337, 2475340, 2619579UNII IFY5PE3ZRW
- Pharmacologic class
- Catecholamine
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
N400338012820followed by a unit qualifier and the quantityPackage 00338-0128-20. 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)
Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride Injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine Bitartrate in Dextrose Injection or Norepinephrine Bitartrate in Sodium Chloride Injection is a catecholamine indicated for restoration of blood pressure in adult patients with acute hypotensive states. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 214313
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 |
|---|---|---|---|---|
| Norepinephrine Bitartrate | Norepinephrine bitartrate 8 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0108 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 16 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0116 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 4 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0112 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 4 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0040 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 8 mg/250mL | Injection, SolutionIntravenous | Baxter Healthcare Corporation | 0338-0042 |