Prescription drug · ANDA
Carvedilol Phosphate NDC 69238-2580
Carvedilol phosphate 80 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-2580-1 | 69238258001 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-1)Marketed from Aug 1, 2023 | |
| 69238-2580-2 | 69238258002 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-2)Marketed from Aug 1, 2023 | |
| 69238-2580-3 | 69238258003 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-3)Marketed from Aug 1, 2023 | |
| 69238-2580-9 | 69238258009 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (69238-2580-9)Marketed from Aug 1, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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)
- Carvedilol Phosphate
- Generic name (nonproprietary)
- carvedilol phosphate
- Active ingredients
- Carvedilol phosphate — 80 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204717
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 69238-2580_7bae176f-58e3-4d75-9609-80079f391e1eSPL ID 7bae176f-58e3-4d75-9609-80079f391e1eSPL set ID dbec7c4b-3db7-4c9d-b5da-e72050ee5743RxCUI 860510, 860516, 860522, 860532UNII EQT531S367
- Pharmacologic class
- alpha-Adrenergic Blocker; 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
N469238258001followed by a unit qualifier and the quantityPackage 69238-2580-01. 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)
Carvedilol phosphate extended-release capsules are an alpha-/beta-adrenergic blocking agent indicated for the treatment of: mild to severe chronic heart failure. ( 1.1 ) left ventricular dysfunction following myocardial infarction in clinically stable patients. ( 1.2 ) hypertension. ( 1.3 ) 1.1 Heart Failure Carvedilol phosphate extended-release capsules are indicated for the treatment of mild-to-severe chronic heart failure of ischemic or cardiomyopathic origin, usually in addition to diuretics, ACE inhibitors, and digitalis, to increase survival and, also, to reduce the risk of hospitalization [see Drug Interactions (7.4) , Clinical Studies (14.1) ]. 1.2 Left Ventricular Dysfunction follow…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 204717
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 |
|---|---|---|---|---|
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1248 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1249 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2579 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1250 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2577 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2578 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1251 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-479 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-482 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-480 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-481 |