Prescription drug · ANDA
Carvedilol NDC 55154-2648
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Cardinal Health 107, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 55154-2648-0 | 55154264800 | 10 BLISTER PACK in 1 BAG (55154-2648-0) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from May 19, 2025 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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
- Cardinal Health 107, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078251
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 55154-2648_24841214-58d6-40aa-b265-9b1fd6b21945SPL ID 24841214-58d6-40aa-b265-9b1fd6b21945SPL set ID bd0f2596-a192-4b0e-836f-4a09816408a4RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0055154264808, 0055154264105, 0055154264006, 0055154264907
- 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
N455154264800followed by a unit qualifier and the quantityPackage 55154-2648-00. 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 in…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078251
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 3.125 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7305 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-033 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7306 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7307 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1463 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7308 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-164 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-162 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-163 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-165 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2119 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1533 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2175 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1128 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4816 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6865 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1937 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4898 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2298 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-131 |
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