Prescription drug · ANDA
Carvedilol NDC 68788-8231
Carvedilol 25 mg/1 · Tablet, Film coated · Oral · Preferred Pharmaceuticals Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68788-8231-1 | 68788823101 | 100 TABLET, FILM COATED in 1 BOTTLE (68788-8231-1)Marketed from Aug 8, 2022 | |
| 68788-8231-3 | 68788823103 | 30 TABLET, FILM COATED in 1 BOTTLE (68788-8231-3)Marketed from Aug 8, 2022 | |
| 68788-8231-9 | 68788823109 | 90 TABLET, FILM COATED in 1 BOTTLE (68788-8231-9)Marketed from Mar 21, 2024 |
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 — 25 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078165
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 68788-8231_e591fdd8-b68b-460b-ae74-8c23b8f65d91SPL ID e591fdd8-b68b-460b-ae74-8c23b8f65d91SPL set ID 8d3937b4-e0dd-4165-9825-bbf5020d79f9RxCUI 200033UNII 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
N468788823101followed by a unit qualifier and the quantityPackage 68788-8231-01. 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 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 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 Carvedilol is indicated to reduce cardiova…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078165
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 | Advagen Pharma Ltd | 72888-034 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-035 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-036 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Ltd | 72888-037 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3970 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-5311 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-431 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-440 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | RedPharm Drug, Inc | 67296-1899 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | RedPharm Drug, Inc | 67296-1901 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2023 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7849 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7850 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2026 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2033 |