Prescription drug · NDA
Coreg CR (carvedilol phosphate) NDC 80725-387
Carvedilol phosphate 40 mg/1 · Capsule, Extended release · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-387-13 | 80725038713 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (80725-387-13)Marketed from Nov 7, 2022 |
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)
- Coreg CR
- Generic name (nonproprietary)
- carvedilol phosphate
- Active ingredients
- Carvedilol phosphate — 40 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Waylis Therapeutics LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 022012
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 80725-387_d756f678-86ff-4187-9cc1-68dd3a383af8SPL ID d756f678-86ff-4187-9cc1-68dd3a383af8SPL set ID d3625d78-6eb6-41fe-8f6f-664965c104c4RxCUI 860510, 860512, 860516, 860518, 860522, 860524, 860532, 860534UNII EQT531S367UPC 0380725387137, 0380725388134, 0380725385133, 0380725383139
- 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
N480725038713followed by a unit qualifier and the quantityPackage 80725-0387-13. 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)
COREG CR is 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 COREG CR is 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 following Myocardial Infarction COREG CR is indicated to reduce cardiovascular mort…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 022012
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 |
|---|---|---|---|---|
| Coreg CRcarvedilol phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Waylis Therapeutics LLC | 80725-383 |
| Coreg CRcarvedilol phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Waylis Therapeutics LLC | 80725-385 |
| Coreg CRcarvedilol phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | Waylis Therapeutics LLC | 80725-388 |