Prescription drug · ANDA
Metoprolol Succinate NDC 72516-031
Metoprolol tartrate 50 mg/1 · Tablet, Extended release · Oral · Oryza Pharmaceuticals, Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72516-031-01 | 7251600310172516003101 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-01)Marketed from Apr 27, 2022 | |
| 72516-031-10 | 7251600311072516003110 | 1000 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-10)Marketed from Apr 27, 2022 | |
| 72516-031-50 | 7251600315072516003150 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (72516-031-50)Marketed from Apr 27, 2022 |
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 tartrate — 50 mg/1
- Dosage form
- Tablet, Extended release
- Route
- Oral
- Labeler
- Oryza Pharmaceuticals, IncNDC labeler code 72516
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 207206
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 72516-031_2b4bd7b3-d6df-e98e-e063-6394a90a7f9dSPL ID 2b4bd7b3-d6df-e98e-e063-6394a90a7f9dSPL set ID 6cfe96df-bd75-432d-b2c2-e26143ca36ddRxCUI 866412, 866419, 866427, 866436UNII W5S57Y3A5LUPC 0372516030018, 0372516033019, 0372516031015
- 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
N472516003101followed by a unit qualifier and the quantityPackage 72516-0031-01. 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 succinate extended-release tablets, metoprolol succinate, 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 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 stro…
Excerpt only. Read the full label for complete information.
About NDC 72516-031
- What is NDC 72516-031?
- 72516-031 is the product NDC for Metoprolol Succinate, Metoprolol tartrate 50 mg/1 tablet, extended release, listed with the FDA by Oryza Pharmaceuticals, Inc. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol Succinate.
- What is the active ingredient?
- Metoprolol tartrate.
- Who is the labeler?
- Oryza Pharmaceuticals, Inc, NDC labeler code 72516. 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 Succinate?
- 250 other product NDCs are listed under this name. See all Metoprolol Succinate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Metoprolol Succinate 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 Succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-0883 | 67046-0883-03 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1685 | 67046-1685-03 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1686 | 67046-1686-03 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Oryza pharmaceuticals Inc. | 72516-025 | 72516-0025-0172516-0025-1072516-0025-50 |
| Metoprolol Succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-684 | 68001-0684-0068001-0684-03 |
| Metoprolol Succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-685 | 68001-0685-0068001-0685-03 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-686 | 68001-0686-0068001-0686-03 |
| Metoprolol Succinate | Metoprolol succinate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-687 | 68001-0687-00 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Coupler LLC | 67046-1650 | 67046-1650-03 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-009 | 53401-0009-3053401-0009-4553401-0009-53+3 more |
Other NDCs under ANDA 207206
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 tartrate 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4190 |
| Metoprolol Succinate | Metoprolol tartrate 50 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6448 |
| Metoprolol Succinate | Metoprolol tartrate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6488 |
| Metoprolol Succinate | Metoprolol tartrate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-6489 |
| Metoprolol Succinate | Metoprolol tartrate 50 mg/1 | Tablet, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 72789-497 |
| Metoprolol Succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-302 |
| Metoprolol Succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-303 |
| Metoprolol Succinate | Metoprolol tartrate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3943 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-304 |
| Metoprolol Succinate | Metoprolol succinate 200 mg/1 | Tablet, Extended releaseOral | Cranbury Pharmaceuticals, LLC | 27808-305 |
| Metoprolol Succinate | Metoprolol tartrate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceuticals, Inc. | 68071-3965 |
| Metoprolol Succinate | Metoprolol tartrate 100 mg/1 | Tablet, Extended releaseOral | Oryza Pharmaceuticals, Inc | 72516-032 |
| Metoprolol Succinate | Metoprolol tartrate 25 mg/1 | Tablet, Extended releaseOral | Oryza Pharmaceuticals, Inc | 72516-030 |
| Metoprolol Succinate | Metoprolol tartrate 200 mg/1 | Tablet, Extended releaseOral | Oryza Pharmaceuticals, Inc | 72516-033 |
| Metoprolol Succinate | Metoprolol tartrate 25 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-4090 |
| Metoprolol Succinate | Metoprolol tartrate 50 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 82804-014 |
| Metoprolol Succinate | Metoprolol tartrate 100 mg/1 | Tablet, Extended releaseOral | Preferred Pharmaceuticals Inc | 68788-8448 |