Prescription drug · ANDA
Metoprolol Tartrate NDC 43063-821
Metoprolol tartrate 50 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-821-30 | 43063082130 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-30)Marketed from Jun 27, 2018 | |
| 43063-821-60 | 43063082160 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-60)Marketed from May 17, 2018 | |
| 43063-821-90 | 43063082190 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-90)Marketed from Jan 5, 2017 | |
| 43063-821-93 | 43063082193 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-821-93)Marketed from Jan 5, 2017 |
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, Film coated
- Route
- Oral
- Labeler
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077739
- Marketing start
- Marketing end
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 43063-821_47cee106-d10c-fb07-e063-6294a90ac517SPL ID 47cee106-d10c-fb07-e063-6294a90ac517SPL set ID 19678edf-934a-45f3-b5da-94d10e9b3248RxCUI 866514UNII W5S57Y3A5LUPC 0343063821305
- 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
N443063082130followed by a unit qualifier and the quantityPackage 43063-0821-30. 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 tablets are 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 tablets are indicated for the treatment of hypertension in adult patients, to lower blood pressure. Lowering blood pressure lo…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077739
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 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-534 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-535 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7362 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7363 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-514 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-953 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Asclemed USA, Inc. | 76420-954 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-549 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-527 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-191 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-080 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Legacy Pharmaceutical Packaging, LLC | 68645-190 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1979 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1974 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-927 |
| Metoprolol Tartrate | Metoprolol tartrate 100 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-938 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-138 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-137 |
| Metoprolol Tartrate | Metoprolol tartrate 50 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-147 |
| Metoprolol Tartrate | Metoprolol tartrate 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-3291 |
Showing 20 of 39.