Prescription drug · ANDA
Metoprolol Tartrate NDC 68083-131
Metoprolol tartrate 5 mg/5mL · Injection · Intravenous · Gland Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68083-131-01 | 6808301310168083013101 | 10 VIAL, GLASS in 1 CARTON (68083-131-01) / 5 mL in 1 VIAL, GLASSMarketed from Oct 6, 2014 |
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 Tartrate
- Generic name (nonproprietary)
- metoprolol tartrate
- Active ingredients
- Metoprolol tartrate — 5 mg/5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Gland Pharma LimitedNDC labeler code 68083
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204205
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68083-131_32f3e39e-0df1-4cd0-96f1-14d69d7b827dSPL ID 32f3e39e-0df1-4cd0-96f1-14d69d7b827dSPL set ID e89cb5ec-e11b-4ca9-b3e3-34a4f144d7feRxCUI 866508UNII W5S57Y3A5L
- 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
N468083013101followed by a unit qualifier and the quantityPackage 68083-0131-01. 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 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 68083-131
- What is NDC 68083-131?
- 68083-131 is the product NDC for Metoprolol Tartrate, Metoprolol tartrate 5 mg/5mL injection, listed with the FDA by Gland Pharma Limited. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol Tartrate.
- What is the active ingredient?
- Metoprolol tartrate.
- Who is the labeler?
- Gland Pharma Limited, NDC labeler code 68083. 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 Tartrate?
- 224 other product NDCs are listed under this name. See all Metoprolol Tartrate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metoprolol Tartrate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Metoprolol Tartratemetoprolol | Metoprolol tartrate 50 mg/1 | TabletOral | St. Mary's Medical Park Pharmacy | 60760-944 | 60760-0944-60 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4748 | 70518-4748-00 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-4714 | 70518-4714-00 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0278 | 55154-0278-00 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-0279 | 55154-0279-00 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | Direct_Rx | 72189-677 | 72189-0677-90 |
| Metoprolol Tartratemetoprolol | Metoprolol tartrate 100 mg/1 | TabletOral | Coupler LLC | 67046-1384 | 67046-1384-03 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | ST. MARY'S MEDICAL PARK PHARMACY | 60760-928 | 60760-0928-90 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | PD-Rx Pharmaceuticals, Inc. | 72789-555 | 72789-0555-90 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Safecor Health, LLC | 48433-073 | 48433-0073-20 |
Other NDCs under ANDA 204205
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 |
|---|---|---|---|---|
| Metoprolol Tartrate | Metoprolol tartrate 1 mg/mL | Injection, SolutionIntravenous | Sagent Pharmaceuticals | 25021-303 |
| Metoprolol Tartrate | Metoprolol tartrate 1 mg/mL | Injection, SolutionIntravenous | Cardinal Health 107, LLC | 55154-1557 |
| Metoprolol Tartrate | Metoprolol tartrate 1 mg/mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7226 |
| Metoprolol Tartrate | Metoprolol tartrate 5 mg/5mL | Injection, SolutionIntravenous | Medical Purchasing Solutions, LLC | 71872-7283 |
| Metoprolol Tartrate | Metoprolol tartrate 5 mg/5mL | Injection, SolutionIntravenous | FOSUN PHARMA USA INC | 72266-122 |
| Metoprolol Tartrate | Metoprolol tartrate 1 mg/mL | Injection, SolutionIntravenous | Almaject, Inc. | 72611-740 |