Prescription drug · NDA
Metoprolol Succinate NDC 63304-011
Metoprolol succinate 200 mg/1 · Capsule, Extended release · Oral · Sun Pharmaceutical Industries Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63304-011-30 | 6330400113063304001130 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (63304-011-30)Marketed from Feb 7, 2018 |
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 — 200 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries Inc.NDC labeler code 63304
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 210428
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 63304-011_32a6b020-3673-469f-8757-741297fb458bSPL ID 32a6b020-3673-469f-8757-741297fb458bSPL set ID 90aa06a3-100f-4466-b950-506303707b01RxCUI 1999031, 1999033, 1999035, 1999037UNII TH25PD4CCBUPC 0363304010305
- 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
N463304001130followed by a unit qualifier and the quantityPackage 63304-0011-30. 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 capsules are beta 1 -selective adrenoceptor blocking agent 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 hospitalization in patients with heart failure. (1.3) 1.1 Hypertension Metoprolol succinate extended-release capsules are indicated for the treatment of hypertension, to lower blood pressure. Lowering blood pressure lowers the risk of fatal and non-fatal cardiovascular events, primar…
Excerpt only. Read the full label for complete information.
About NDC 63304-011
- What is NDC 63304-011?
- 63304-011 is the product NDC for Metoprolol Succinate, Metoprolol succinate 200 mg/1 capsule, extended release, listed with the FDA by Sun Pharmaceutical Industries Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Metoprolol Succinate.
- What is the active ingredient?
- Metoprolol succinate.
- Who is the labeler?
- Sun Pharmaceutical Industries Inc., NDC labeler code 63304. 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 NDA 210428
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 |
|---|---|---|---|---|
| Kapspargometoprolol succinate | Metoprolol succinate 25 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-008 |
| Kapspargometoprolol succinate | Metoprolol succinate 50 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-009 |
| Kapspargometoprolol succinate | Metoprolol succinate 100 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-010 |
| Kapspargometoprolol succinate | Metoprolol succinate 200 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-011 |
| Metoprolol Succinate | Metoprolol succinate 25 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries Inc. | 63304-008 |
| Metoprolol Succinate | Metoprolol succinate 50 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries Inc. | 63304-009 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries Inc. | 63304-010 |