Prescription drug · ANDA
Metoprolol Tartrate NDC 53401-016
Metoprolol tartrate 50 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 53401-016-60 | 53401001660 | 90 TABLET in 1 BOTTLE (53401-016-60)Marketed from Jun 16, 2026 | |
| 53401-016-70 | 53401001670 | 120 TABLET in 1 BOTTLE (53401-016-70)Marketed from Jul 13, 2026 | |
| 53401-016-80 | 53401001680 | 180 TABLET in 1 BOTTLE (53401-016-80)Marketed from Jun 16, 2026 | |
| 53401-016-92 | 53401001692 | 270 TABLET in 1 BOTTLE (53401-016-92)Marketed from Jun 16, 2026 |
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 — 50 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 53401
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 200981
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 53401-016_5683e0aa-9246-2c43-e063-6294a90a822bSPL ID 5683e0aa-9246-2c43-e063-6294a90a822bSPL set ID 5476c4fc-ab09-ee1a-e063-6394a90a7a1bRxCUI 866514UNII 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 HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N453401001660followed by a unit qualifier and the quantityPackage 53401-0016-60. 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 is a beta-adrenergic blocker indicated for the treatment of: Hypertension, to lower blood pressure. Lowering blood pressure reduces the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. ( 1.1 ) Angina Pectoris. ( 1.2 ) Myocardial Infarction, to reduce the risk of cardiovascular mortality when used in conjunction with intravenous metoprolol therapy in patients with definite or suspected acute myocardial infarction in hemodynamically stable patients. ( 1.3 ) 1.1 Hypertension Metoprolol tartrate is indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure lowers the risk of f…
Excerpt only. Read the full label for complete information.
About NDC 53401-016
- What is NDC 53401-016?
- 53401-016 is the product NDC for Metoprolol Tartrate, Metoprolol tartrate 50 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 4 package NDCs, 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?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 53401. 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?
- 221 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 200981
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 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7568 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | RedPharm Drug, Inc | 67296-1903 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-210 |
| Metoprolol Tartrate | Metoprolol tartrate 75 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-211 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7567 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-9745 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | Advagen Pharma Ltd | 72888-212 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7569 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | RedPharm Drug, Inc | 67296-1903 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | A-S Medication Solutions | 50090-7570 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-524 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-884 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-566 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-186 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-012 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-184 |
| Metoprolol Tartrate | Metoprolol tartrate 37.5 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-185 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-011 |
| Metoprolol Tartrate | Metoprolol tartrate 75 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-187 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | TabletOral | ASCLEMED USA INC. | 87063-188 |
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