Prescription drug · ANDA
Norepinephrine Bitartrate NDC 25021-316
Norepinephrine bitartrate 1 mg/mL · Injection, Solution · Intravenous · Sagent Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 25021-316-04 | 2502103160425021031604 | 10 VIAL in 1 CARTON (25021-316-04) / 4 mL in 1 VIALMarketed from Jul 1, 2021 |
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
- Route
- Intravenous
- Labeler
- Sagent PharmaceuticalsNDC labeler code 25021
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214323
- Marketing start
- Listing expires
- Other FDA classes
- Catecholamines (Chemical structure)
- Identifiers
- Product ID 25021-316_61b38873-cf8d-48b6-b126-2e0a32ac5f7aSPL ID 61b38873-cf8d-48b6-b126-2e0a32ac5f7aSPL set ID cc9ecec5-3bd7-4132-9745-7666bac8ceacRxCUI 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
N425021031604followed by a unit qualifier and the quantityPackage 25021-0316-04. 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 25021-316
- What is NDC 25021-316?
- 25021-316 is the product NDC for Norepinephrine Bitartrate, Norepinephrine bitartrate 1 mg/mL injection, solution, listed with the FDA by Sagent Pharmaceuticals. 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?
- Sagent Pharmaceuticals, NDC labeler code 25021. 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 |
Other NDCs under ANDA 214323
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 | InjectionIntravenous | Baxter Healthcare Company | 43066-997 |
| Norepinephrine bitartrate | Norepinephrine bitartrate 1 mg/mL | InjectionIntravenous | Gland Pharma Limited | 68083-437 |