Prescription drug · ANDA
Carvedilol NDC 0093-0051
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Teva Pharmaceuticals USA, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0093-0051-01 | 00093005101 | 100 TABLET, FILM COATED in 1 BOTTLE (0093-0051-01)Marketed from Sep 6, 2007 | |
| 0093-0051-05 | 00093005105 | 500 TABLET, FILM COATED in 1 BOTTLE (0093-0051-05)Marketed from Dec 2, 2008 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076373
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 0093-0051_3d07d8c6-ffea-41c3-a50c-4e3d723de14fSPL ID 3d07d8c6-ffea-41c3-a50c-4e3d723de14fSPL set ID 68c275e8-992a-4520-8065-ab6d615d89ccRxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0300930135019, 0300937296010, 0300930051012, 0300937295013
- 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
N400093005101followed by a unit qualifier and the quantityPackage 00093-0051-01. 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 indicat…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076373
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 | Teva Pharmaceuticals USA, Inc. | 0093-0135 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8387 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8388 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8389 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8390 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-138 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7890 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-191 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-225 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-270 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7295 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7296 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-072 |