Prescription drug · ANDA
Norepinephrine bitartrate NDC 67457-852
Norepinephrine bitartrate 1 mg/mL · Injection, Solution, Concentrate · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-852-04 | 6745708520467457085204 | 10 VIAL, SINGLE-DOSE in 1 CARTON (67457-852-04) / 4 mL in 1 VIAL, SINGLE-DOSE (67457-852-00)Marketed from Oct 15, 2018 |
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 LLCNDC labeler code 67457
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 211242
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)
- Identifiers
- Product ID 67457-852_af3a6bd3-bbc9-43a9-a277-b55ae59d5097SPL ID af3a6bd3-bbc9-43a9-a277-b55ae59d5097SPL set ID d3ea12e0-88cc-49b0-b06e-5199ecd6ca69RxCUI 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
N467457085204followed by a unit qualifier and the quantityPackage 67457-0852-04. 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.
About NDC 67457-852
- What is NDC 67457-852?
- 67457-852 is the product NDC for Norepinephrine bitartrate, Norepinephrine bitartrate 1 mg/mL injection, solution, concentrate, listed with the FDA by Mylan Institutional LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Norepinephrine bitartrate.
- What is the active ingredient?
- Norepinephrine bitartrate.
- Who is the labeler?
- Mylan Institutional LLC, NDC labeler code 67457. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Norepinephrine bitartrate?
- 26 other product NDCs are listed under this name. See all Norepinephrine bitartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Norepinephrine bitartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| norepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, SolutionIntravenous | Avenacy, LLC | 83634-307 | 83634-0307-04 |
| norepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Novadoz Pharmaceuticals LLC | 72205-241 | 72205-0241-07 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Anthea Pharma Private Limited | 83854-017 | 83854-0017-10 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | BIOCON PHARMA INC. | 70377-121 | 70377-0121-12 |
| Norepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Camber Pharmaceuticals, Inc. | 31722-372 | 31722-0372-32 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | Injection, Solution, ConcentrateIntravenous | Meitheal Pharmaceuticals Inc. | 71288-439 | 71288-0439-05 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | InjectionIntravenous | Rising Pharma Holdings, Inc. | 64980-630 | 64980-0630-41 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | InjectionIntravenous | Caplin Steriles Limited | 65145-133 | 65145-0133-10 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | InjectionIntravenous | BE Pharmaceuticals Inc. | 71839-143 | 71839-0143-1071839-0143-25 |
| Norepinephrine Bitartrate | Norepinephrine bitartrate 1 mg/mL | InjectionIntravenous | NorthStar Rx LLC | 72603-180 | 72603-0180-10 |