Prescription drug · ANDA
Carvedilol NDC 51655-943
Carvedilol 6.25 mg/1 · Tablet, Film coated · Oral · Northwind Health Company, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51655-943-18 | 51655094318 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (51655-943-18)Marketed from Mar 30, 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)
- Carvedilol
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 6.25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078384
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 51655-943_497471bb-541b-f945-e063-6294a90adbb2SPL ID 497471bb-541b-f945-e063-6294a90adbb2SPL set ID df7415ac-e475-19c9-e053-2995a90afa71RxCUI 200031UNII 0K47UL67F2
- 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
N451655094318followed by a unit qualifier and the quantityPackage 51655-0943-18. 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 Tablet 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 Carvedilol Tablets 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 Clinical Studies ( 14.1 )]. 1.2 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol Tablet is indicated to reduce cardiovascular mortal…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078384
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 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-042 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-039 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-040 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-041 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-653 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1407 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-110 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-111 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-112 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-113 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1813 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-062 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-063 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-066 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-183 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-067 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1457 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5275 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2474 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-713 |
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