Prescription drug · ANDA
Carvedilol NDC 68462-164
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Glenmark Pharmaceuticals Inc., USA
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 68462-164-01 | 68462016401 | 100 TABLET, FILM COATED in 1 BOTTLE (68462-164-01)Marketed from Sep 5, 2007 | |
| 68462-164-05 | 68462016405 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-164-05)Marketed from Sep 5, 2007 | |
| 68462-164-10 | 68462016410 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-164-10)Marketed from Sep 5, 2007 | |
| 68462-164-18 | 68462016418 | 180 TABLET, FILM COATED in 1 BOTTLE (68462-164-18)Marketed from Dec 10, 2014 | |
| 68462-164-60 | 68462016460 | 60 TABLET, FILM COATED in 1 BOTTLE (68462-164-60)Marketed from Sep 5, 2007 |
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
- 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 68462-164_5f5b2d20-cc2a-4e91-b2b9-260e7438ab2cSPL ID 5f5b2d20-cc2a-4e91-b2b9-260e7438ab2cSPL set ID c4a21f67-7812-4634-beba-f8e85c63c5f2RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0368462162019, 0368462163016, 0368462164013, 0368462165010
- 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
N468462016401followed by a unit qualifier and the quantityPackage 68462-0164-01. 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 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 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 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2773 |
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