Prescription drug · ANDA
Carvedilol NDC 58657-752
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Method Pharmaceuticals, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 58657-752-01 | 58657075201 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-752-01)Marketed from Dec 3, 2024 | |
| 58657-752-50 | 58657075250 | 500 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (58657-752-50)Marketed from Dec 3, 2024 |
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 — 12.5 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Method Pharmaceuticals, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078786
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 58657-752_41b3fac8-087e-fa78-e063-6294a90a75e1SPL ID 41b3fac8-087e-fa78-e063-6294a90a75e1SPL set ID a6ab5da0-8f22-491d-b007-85d9d4901828RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0358657753016, 0358657751012, 0358657752019, 0358657750015
- 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
N458657075201followed by a unit qualifier and the quantityPackage 58657-0752-01. 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 tablets, USP 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, USP 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, USP are in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078786
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 | Advagen Pharma Limited | 72888-500 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-499 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-501 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-502 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-753 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-750 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Method Pharmaceuticals, LLC | 58657-751 |