Prescription drug · ANDA
Carvedilol NDC 63187-131
Carvedilol 25 mg/1 · Tablet, Film coated · Oral · Proficient Rx LP
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63187-131-30 | 63187013130 | 30 TABLET, FILM COATED in 1 BOTTLE (63187-131-30)Marketed from May 26, 2021 | |
| 63187-131-60 | 63187013160 | 60 TABLET, FILM COATED in 1 BOTTLE (63187-131-60)Marketed from May 26, 2021 | |
| 63187-131-90 | 63187013190 | 90 TABLET, FILM COATED in 1 BOTTLE (63187-131-90)Marketed from Aug 1, 2014 |
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 — 25 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 078251
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 63187-131_66dda826-2d3f-466b-ab05-42b7cf892410SPL ID 66dda826-2d3f-466b-ab05-42b7cf892410SPL set ID c03bd9d7-1e0b-49da-a14a-32e712dc3a2dRxCUI 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
N463187013130followed by a unit qualifier and the quantityPackage 63187-0131-30. 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 USP are an alpha/beta-adrenergic blocking agent indicated for the treatment of: • Left ventricular dysfunction following myocardial infarction in clinically stable patients ( 1.2 ) • Hypertension ( 1.3 ) 1.2 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 (14.2) ]. 1.3 Hypertension Carvedilol tablets USP are indicated for the management of essential hypertension [see Clinical Studi…
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 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-164 |
| 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 | NuCare Pharmaceuticals,Inc. | 68071-2773 |
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