Prescription drug · NDA
Toprol XL (metoprolol succinate) NDC 70842-112
Metoprolol succinate 100 mg/1 · Tablet, Extended release · Oral · Melinta Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70842-112-02 | 70842011202 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (70842-112-02)Marketed from Jul 3, 2023 |
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)
- Toprol XL
- Generic name (nonproprietary)
- metoprolol succinate
- Active ingredients
- Metoprolol succinate — 100 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Melinta Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 019962
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 70842-112_a9037cc4-2d8d-45d5-9b89-2cd22c50d0a2SPL ID a9037cc4-2d8d-45d5-9b89-2cd22c50d0a2SPL set ID 496ddfaa-7c9c-4888-b747-a210249b367aRxCUI 866412, 866414, 866419, 866421, 866427, 866429, 866436, 866438UNII TH25PD4CCBUPC 0370842113023, 0370842111029, 0370842112026, 0370842110022
- 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
N470842011202followed by a unit qualifier and the quantityPackage 70842-0112-02. 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)
TOPROL-XL, metoprolol succinate, 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 ) Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure ( 1.3 ) 1.1 Hypertension TOPROL-XL is indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primarily strokes and myocardial infarctions. These benefits have been seen in …
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 019962
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 |
|---|---|---|---|---|
| Toprol XLmetoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-035 |
| Toprol XLmetoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Melinta Therapeutics, LLC | 70842-111 |
| Toprol XLmetoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Melinta Therapeutics, LLC | 70842-110 |
| Toprol XLmetoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Extended releaseOral | Melinta Therapeutics, LLC | 70842-113 |
| Metoprolol Succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 71205-162 |