Prescription drug · ANDA
Metoprolol succinate NDC 0904-6323
Metoprolol succinate 50 mg/1 · Tablet, Film coated, Extended release · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-6323-61 | 0090463236100904632361 | 100 BLISTER PACK in 1 CARTON (0904-6323-61) / 1 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACKMarketed from Sep 10, 2012 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 50 mg/1
- Dosage form
- Tablet, Film coated, Extended release
- Route
- Oral
- Labeler
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090617
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic beta-Antagonists (Mechanism)
- Identifiers
- Product ID 0904-6323_fb44a568-5b01-45b0-a72d-6eed8ee087ddSPL ID fb44a568-5b01-45b0-a72d-6eed8ee087ddSPL set ID 14ab9921-4651-4abc-92dc-aab1719b6bb0RxCUI 866427, 866436UNII 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
N400904632361followed by a unit qualifier and the quantityPackage 00904-6323-61. 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.
About NDC 0904-6323
- What is NDC 0904-6323?
- 0904-6323 is the product NDC for Metoprolol succinate, Metoprolol succinate 50 mg/1 tablet, film coated, extended release, listed with the FDA by Major Pharmaceuticals. 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 090617
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 25 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-010 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Aphena Pharma Solutions - Tennessee, LLC | 53401-009 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | NuCare Pharmaceutcals, Inc. | 68071-3828 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-7280 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0149 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | Bryant Ranch Prepack | 71335-0158 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Cardinal Health 107, LLC | 55154-2642 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Northstar Rx LLC | 72603-142 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Northstar Rx LLC | 72603-143 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7118 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | A-S Medication Solutions | 50090-7117 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-540 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7823 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | AvPAK | 50268-541 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | PD-Rx Pharmaceuticals, Inc. | 43063-624 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Extended releaseOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-7824 |
| Metoprolol succinate | Metoprolol succinate 50 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-347 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Dr. Reddy's Laboratories Inc | 75907-344 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Major Pharmaceuticals | 0904-6322 |
| Metoprolol succinate | Metoprolol succinate 25 mg/1 | Tablet, Film coated, Extended releaseOral | Quallent Pharmaceuticals Health LLC | 82009-113 |
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