Prescription drug · NDA
Coreg (carvedilol) NDC 80725-139
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Waylis Therapeutics LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 80725-139-20 | 80725013920 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (80725-139-20)Marketed from Apr 15, 2023 |
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
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Waylis Therapeutics LLC
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020297
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 80725-139_514a36dd-5646-48b3-99cc-1457af6cb7d8SPL ID 514a36dd-5646-48b3-99cc-1457af6cb7d8SPL set ID 07c619c6-4a0c-445e-94fa-664a54f68a39RxCUI 200031, 200032, 200033, 212388, 212389, 212390, 686924, 686926UNII 0K47UL67F2UPC 0380725142200, 0380725141203, 0380725140206, 0380725139200
- 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
N480725013920followed by a unit qualifier and the quantityPackage 80725-0139-20. 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)
1. INDICATIONS AND USAGE COREG 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 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 is indicated to reduce cardiov…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 020297
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 |
|---|---|---|---|---|
| Coregcarvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Waylis Therapeutics LLC | 80725-142 |
| Coregcarvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Waylis Therapeutics LLC | 80725-140 |
| Coregcarvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Waylis Therapeutics LLC | 80725-141 |