Prescription drug · ANDA
metoprolol succinate NDC 71205-801
Metoprolol succinate 100 mg/1 · Tablet, Film coated, Extended release · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71205-801-30 | 71205080130 | 30 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-801-30)Marketed from May 18, 2023 | |
| 71205-801-60 | 71205080160 | 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-801-60)Marketed from May 18, 2023 | |
| 71205-801-90 | 71205080190 | 90 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (71205-801-90)Marketed from May 18, 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)
- metoprolol succinate
- Generic name (nonproprietary)
- metoprolol succinate
- Active ingredients
- Metoprolol succinate — 100 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204161
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 71205-801_57e33bcf-b380-44bb-b96e-3a637af6233aSPL ID 57e33bcf-b380-44bb-b96e-3a637af6233aSPL set ID 57e33bcf-b380-44bb-b96e-3a637af6233aRxCUI 866412, 866436UNII TH25PD4CCBUPC 0371205800307, 0371205801304
- 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
N471205080130followed by a unit qualifier and the quantityPackage 71205-0801-30. 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 succinate extended-release 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 ) • Heart Failure, to reduce the risk of cardiovascular mortality and heart failure hospitalizations in patients with heart failure. ( 1.3 ) 1.1 Hypertension Metoprolol succinate extended-release tablets are 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204161
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 succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-519 |
| metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-368 |
| metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 45963-678 |
| metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 45963-676 |
| metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 45963-677 |
| metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Actavis Pharma, Inc. | 45963-709 |
| metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-193 |
| metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Proficient Rx LP | 71205-800 |
| metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Northwind Health Company, LLC | 51655-934 |