Prescription drug · ANDA
Carvedilol NDC 82009-125
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Quallent Pharmaceuticals Health LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82009-125-05 | 82009012505 | 500 TABLET, FILM COATED in 1 BOTTLE (82009-125-05)Marketed from Aug 3, 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)
- Carvedilol
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077614
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 82009-125_4645b74b-2d36-4e20-9a06-e300949eb89eSPL ID 4645b74b-2d36-4e20-9a06-e300949eb89eSPL set ID eb892787-edd0-4ab6-aef2-2d0216384395RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0382009125053, 0382009127057, 0382009128054
- 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
N482009012505followed by a unit qualifier and the quantityPackage 82009-0125-05. 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 tablets 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 tablets 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 following Myocardial Infarction Carvedilol tablets are indicated …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077614
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 | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0426 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-181 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-664 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-663 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-537 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-030 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-029 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-034 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4060 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6742 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0336 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2101 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4070 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0840 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3138 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2230 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-126 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-127 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-128 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-151 |
Showing 20 of 39.