Prescription drug · ANDA
Metoprolol (Metoprolol tartrate) NDC 65219-665
Metoprolol tartrate 5 mg/5mL · Injection, Solution · Intravenous · Fresenius Kabi USA, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65219-665-05 | 6521906650565219066505 | 10 VIAL in 1 TRAY (65219-665-05) / 5 mL in 1 VIAL (65219-665-01)Marketed from Dec 13, 2024 |
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)
- Metoprolol
- Generic name (nonproprietary)
- metoprolol tartrate
- Active ingredients
- Metoprolol tartrate — 5 mg/5mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Fresenius Kabi USA, LLCNDC labeler code 65219
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 091045
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 65219-665_ccb1a15e-c943-4042-ae46-550bdabfc96bSPL ID ccb1a15e-c943-4042-ae46-550bdabfc96bSPL set ID ccb1a15e-c943-4042-ae46-550bdabfc96bRxCUI 866508UNII W5S57Y3A5LUPC 0365219665014
- Pharmacologic class
- beta-Adrenergic Blocker
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
N465219066505followed by a unit qualifier and the quantityPackage 65219-0665-05. 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)
Metoprolol tartrate injection is indicated in the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy. Metoprolol tartrate injection is a beta - adrenergic receptor inhibitor indicated for the treatment of definite or suspected acute myocardial infarction in hemodynamically stable patients to reduce cardiovascular mortality when used in conjunction with oral metoprolol maintenance therapy ( 1 ).
Excerpt only. Read the full label for complete information.
About NDC 65219-665
- What is NDC 65219-665?
- 65219-665 is the product NDC for Metoprolol (metoprolol tartrate), Metoprolol tartrate 5 mg/5mL injection, solution, listed with the FDA by Fresenius Kabi USA, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol (Metoprolol tartrate).
- What is the active ingredient?
- Metoprolol tartrate.
- Who is the labeler?
- Fresenius Kabi USA, LLC, NDC labeler code 65219. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Metoprolol?
- 5 other product NDCs are listed under this name. See all Metoprolol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metoprolol products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metoprololmetoprolol tartrate injection | Metoprolol tartrate 5 mg/5mL | InjectionIntravenous | Oneosource Specialty Pharma Limited | 83270-177 | 83270-0177-10 |
| Metoprololmetoprolol tartrate | Metoprolol tartrate 5 mg/5mL | InjectionIntravenous | Baxter Healthcare Corporation | 36000-033 | 36000-0033-10 |
| Metoprololmetoprolol tartrate | Metoprolol tartrate 5 mg/5mL | InjectionIntravenous | Cardinal Health 107, LLC | 55154-4451 | 55154-4451-05 |
| Metoprololmetoprolol tartrate | Metoprolol tartrate 5 mg/5mL | InjectionIntravenous | Medical Purchasing Solutions, LLC | 71872-7155 | 71872-7155-01 |
| Metoprololmetoprolol tartrate | Metoprolol tartrate 5 mg/5mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-660 | 63323-0660-05 |
Other NDCs under ANDA 091045
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 |
|---|---|---|---|---|
| Metoprololmetoprolol tartrate | Metoprolol tartrate 5 mg/5mL | Injection, SolutionIntravenous | Fresenius Kabi USA, LLC | 63323-660 |
| Metoprolol Tartrate | Metoprolol tartrate 5 mg/5mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1365 |