Prescription drug · ANDA
Carvedilol Phosphate NDC 51407-053
Carvedilol phosphate 80 mg/1 · Capsule, Extended release · Oral · Golden State Medical Supply, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 51407-053-30 | 51407005330 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (51407-053-30)Marketed from Feb 16, 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 Phosphate
- Generic name (nonproprietary)
- carvedilol phosphate
- Active ingredients
- Carvedilol phosphate — 80 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 090132
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 51407-053_47c099ed-1220-236c-e063-6294a90a968eSPL ID 47c099ed-1220-236c-e063-6294a90a968eSPL set ID 669ec7f8-f27d-4048-a784-00ca903cc658RxCUI 860510, 860516, 860522, 860532UNII EQT531S367
- 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
N451407005330followed by a unit qualifier and the quantityPackage 51407-0053-30. 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 phosphate extended-release capsules 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 phosphate extended-release capsules 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…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 090132
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 Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-050 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-051 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-052 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-1551 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 16714-228 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 16714-227 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 16714-229 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 16714-230 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9707 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-663 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-666 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-9634 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-664 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-665 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 63629-9635 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0308 |