Prescription drug · ANDA
Norepinephrine bitartrate NDC 72078-002
Norepinephrine bitartrate 1 mg/mL · Injection, Solution, Concentrate · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72078-002-04 | 72078000204 | 10 VIAL, SINGLE-DOSE in 1 CARTON (72078-002-04) / 4 mL in 1 VIAL, SINGLE-DOSE (72078-002-00)Marketed from Dec 4, 2020 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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 — 1 mg/mL
- Dosage form
- Injection, Solution, Concentrate
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211242
- Marketing start
- Marketing end
- Other FDA classes
- Catecholamines (Chemical structure)
- Identifiers
- Product ID 72078-002_056fa81a-9d45-4ce1-9b2e-3f755f2c36a4SPL ID 056fa81a-9d45-4ce1-9b2e-3f755f2c36a4SPL set ID 7a4950ea-6369-4dd5-97be-df21a5a5055fRxCUI 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
N472078000204followed by a unit qualifier and the quantityPackage 72078-0002-04. 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 injection is indicated to raise blood pressure in adult patients with severe, acute hypotension. Norepinephrine bitartrate 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 ANDA 211242
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 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Mylan Institutional LLC | 67457-852 |