Prescription drug · ANDA
Metoprolol succinate NDC 68001-119
Metoprolol succinate 100 mg/1 · Tablet, Extended release · Oral · BluePoint Laboratories
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68001-119-00 | 68001011900 | 100 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-119-00)Marketed from Nov 25, 2013 | |
| 68001-119-03 | 68001011903 | 500 TABLET, EXTENDED RELEASE in 1 BOTTLE (68001-119-03)Marketed from Nov 25, 2013 |
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, Extended release
- Route
- Oral
- Labeler
- BluePoint Laboratories
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078889
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 68001-119_1aeaf7d4-6a9a-49c8-8e09-6f4411462ee4SPL ID 1aeaf7d4-6a9a-49c8-8e09-6f4411462ee4SPL set ID 5ef12832-15cd-40f4-bf11-6cea7e48ff7fRxCUI 866412, 866419UNII TH25PD4CCBUPC 0368001119009, 0368001120005
- 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
N468001011900followed by a unit qualifier and the quantityPackage 68001-0119-00. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
Metoprolol succinate extended-release tablets, metoprolol succinate, is a beta 1 -selective adrenoceptor blocking agent. Metoprolol succinate extended-release tablets are 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 - for the treatment of stable, symptomatic (NYHA Class II or III) heart failure of ischemic, hypertensive, or cardiomyopathic origin. (1.3) 1.1 Hypertension Metoprolol succinate extended-release tablets are indicated for the treatment of hypertension, to lower blood pressure. …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078889
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 200 mg/1 | Tablet, Film coated, Extended releaseOral | Bryant Ranch Prepack | 71335-3134 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | REMEDYREPACK INC. | 70518-4456 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7825 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-841 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | REMEDYREPACK INC. | 70518-2080 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-542 |
| Metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-543 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-115 |
| Metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-116 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6324 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-4347 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | Proficient Rx LP | 63187-768 |
| Metoprolol Succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | Direct_Rx | 61919-334 |
| Metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Extended releaseOral | BluePoint Laboratories | 68001-120 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-468 |
| Metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddy's Laboratories Limited | 55111-469 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7069 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7070 |
| Metoprolol succinate | Metoprolol succinate 100 mg/1 | Tablet, Film coated, Extended releaseOral | Northstar Rx LLC | 72603-144 |
| Metoprolol succinate | Metoprolol succinate 200 mg/1 | Tablet, Film coated, Extended releaseOral | Northstar Rx LLC | 72603-145 |
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