Prescription drug · NDA
Levophed (Norepinephrine bitartrate) NDC 0409-0161
Norepinephrine bitartrate 1 mg/mL · Injection, Solution, Concentrate · Intravenous · Hospira, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0409-0161-10 | 0040901611000409016110 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0409-0161-10) / 4 mL in 1 VIAL, SINGLE-DOSE (0409-0161-01)Marketed from Mar 11, 2024 |
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)
- Levophed
- Generic name (nonproprietary)
- norepinephrine bitartrate
- Active ingredients
- Norepinephrine bitartrate — 1 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Hospira, Inc.NDC labeler code 0409
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 007513
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)
- Identifiers
- Product ID 0409-0161_0fe551f3-b031-4c1b-b567-cc2fc6a52105SPL ID 0fe551f3-b031-4c1b-b567-cc2fc6a52105SPL set ID 2c7dd2b0-cc10-4db6-bf56-6eb154ebeb10RxCUI 209217, 242969UNII 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
N400409016110followed by a unit qualifier and the quantityPackage 00409-0161-10. 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)
LEVOPHED is indicated to raise blood pressure in adult patients with severe, acute hypotension. LEVOPHED 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.
About NDC 0409-0161
- What is NDC 0409-0161?
- 0409-0161 is the product NDC for Levophed (norepinephrine bitartrate), Norepinephrine bitartrate 1 mg/mL injection, solution, concentrate, listed with the FDA by Hospira, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Levophed (Norepinephrine bitartrate).
- What is the active ingredient?
- Norepinephrine bitartrate.
- Who is the labeler?
- Hospira, Inc., NDC labeler code 0409. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Levophed?
- 1 other product NDC are listed under this name. See all Levophed NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Levophed products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Levophednorepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 0409-3375 | 00409-3375-04 |
Other NDCs under NDA 007513
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 |
|---|---|---|---|---|
| Levophednorepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Hospira, Inc. | 0409-3375 |
| Levophed(R) Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1315 |