Prescription drug · ANDA
Carvedilol NDC 63187-570
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-570-60 | 63187057060 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-570-60)Marketed from Dec 1, 2018 | |
| 63187-570-90 | 63187057090 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-570-90)Marketed from Dec 1, 2018 |
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 — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Proficient Rx LP
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077614
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 63187-570_7a3df1e2-dfa6-44b3-a2cc-0fb9adc28ae3SPL ID 7a3df1e2-dfa6-44b3-a2cc-0fb9adc28ae3SPL set ID 0bfea06d-7abe-407a-80a4-d15d373569f7RxCUI 686924UNII 0K47UL67F2UPC 0363187570606
- 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
N463187057060followed by a unit qualifier and the quantityPackage 63187-0570-60. 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)
1. INDICATIONS AND USAGE Carvedilol tablets, USP is an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Left ventricular dysfunction following myocardial infarction in clinically stable patients( 1.1 ) • Hypertension( 1.2 ) 1.1 Left Ventricular Dysfunction Following Myocardial Infarction Carvedilol tablets, USP are indicated to reduce cardiovascular mortality in clinically stable patients who have survived the acute phase of a myocardial infarction and have a left ventricular ejection fraction of ≤40% (with or without symptomatic heart failure) [see Clinical Studies (14.1)]. 1.2 Hypertension Carvedilol tablets, USP are indicated for the management of essential hypertens…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077614
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 | REMEDYREPACK INC. | 70518-0426 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-181 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-664 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-663 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-537 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-030 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-029 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-034 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4060 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6742 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0336 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2101 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4070 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0840 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3138 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2230 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-126 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-125 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-127 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-128 |
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