Prescription drug · NDA
Kapspargo (Metoprolol succinate) NDC 10631-009
Metoprolol succinate 50 mg/1 · Capsule, Extended release · Oral · Sun Pharmaceutical Industries, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10631-009-30 | 1063100093010631000930 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (10631-009-30)Marketed from Mar 15, 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)
- Kapspargo
- Generic name (nonproprietary)
- metoprolol succinate
- Active ingredients
- Metoprolol succinate — 50 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Sun Pharmaceutical Industries, Inc.NDC labeler code 10631
- 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 10631-009_b982da20-735c-49d8-ad1f-6a831194db87SPL ID b982da20-735c-49d8-ad1f-6a831194db87SPL set ID 9cfa55b4-15c6-40f7-b6e5-41096ee51bfcRxCUI 1999031, 1999033, 1999035, 1999037, 2047766, 2047769, 2047772, 2047775UNII TH25PD4CCB
- 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
N410631000930followed by a unit qualifier and the quantityPackage 10631-0009-30. 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)
KAPSPARGO Sprinkle is a beta 1 -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 KAPSPARGO Sprinkle 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 c…
Excerpt only. Read the full label for complete information.
About NDC 10631-009
- What is NDC 10631-009?
- 10631-009 is the product NDC for Kapspargo (metoprolol succinate), Metoprolol succinate 50 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?
- Kapspargo (Metoprolol Succinate).
- What is the active ingredient?
- Metoprolol succinate.
- Who is the labeler?
- Sun Pharmaceutical Industries, Inc., NDC labeler code 10631. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Kapspargo?
- 3 other product NDCs are listed under this name. See all Kapspargo NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Kapspargo products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Kapspargometoprolol succinate | Metoprolol succinate 25 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-008 | 10631-0008-30 |
| Kapspargometoprolol succinate | Metoprolol succinate 100 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-010 | 10631-0010-30 |
| Kapspargometoprolol succinate | Metoprolol succinate 200 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 10631-011 | 10631-0011-30 |
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 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 |
| Metoprolol Succinate | Metoprolol succinate 200 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries Inc. | 63304-011 |