Prescription drug · ANDA
Carvedilol NDC 43063-125
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · PD-Rx Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 43063-125-90 | 43063012590 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-125-90)Marketed from Jul 31, 2024 | |
| 43063-125-93 | 43063012593 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (43063-125-93)Marketed from Jun 20, 2012 |
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
- PD-Rx Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078332
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 43063-125_41375a05-871b-6afb-e063-6294a90a48f9SPL ID 41375a05-871b-6afb-e063-6294a90a48f9SPL set ID 2be8635b-5733-1ed4-e054-00144ff88e88RxCUI 200032UNII 0K47UL67F2UPC 0343063125939
- 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
N443063012590followed by a unit qualifier and the quantityPackage 43063-0125-90. 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 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 indicated to reduce ca…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 078332
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 | PD-Rx Pharmaceuticals, Inc. | 43063-833 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4600 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-126 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2079 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-132 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 43063-129 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-409 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1069 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-447 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-142 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-941 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-143 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-144 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Aurobindo Pharma Limited | 65862-145 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-946 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-0273 |