Prescription drug · ANDA
Carvedilol Phosphate NDC 0115-1251
Carvedilol phosphate 80 mg/1 · Capsule, Extended release · Oral · Amneal Pharmaceuticals of New York LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0115-1251-01 | 0011512510100115125101 | 100 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1251-01)Marketed from Jan 1, 2024 | |
| 0115-1251-03 | 0011512510300115125103 | 1000 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1251-03)Marketed from Jan 1, 2024 | |
| 0115-1251-08 | 0011512510800115125108 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1251-08)Marketed from Jan 1, 2024 | |
| 0115-1251-10 | 0011512511000115125110 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (0115-1251-10)Marketed from Jan 1, 2024 |
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 Phosphate
- Generic name (nonproprietary)
- carvedilol phosphate
- Active ingredients
- Carvedilol phosphate — 80 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Amneal Pharmaceuticals of New York LLCNDC labeler code 0115
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 204717
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 0115-1251_2b361073-255d-48a0-a662-01291755f15bSPL ID 2b361073-255d-48a0-a662-01291755f15b
- 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
N400115125101followed by a unit qualifier and the quantityPackage 00115-1251-01. 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
The FDA listing for this product does not reference a label (SPL) set.
About NDC 0115-1251
- What is NDC 0115-1251?
- 0115-1251 is the product NDC for Carvedilol Phosphate, Carvedilol phosphate 80 mg/1 capsule, extended release, listed with the FDA by Amneal Pharmaceuticals of New York LLC. It has 4 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carvedilol Phosphate.
- What is the active ingredient?
- Carvedilol phosphate.
- Who is the labeler?
- Amneal Pharmaceuticals of New York LLC, NDC labeler code 0115. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Carvedilol Phosphate?
- 28 other product NDCs are listed under this name. See all Carvedilol Phosphate NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carvedilol Phosphate products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Coupler LLC | 67046-1551 | 67046-1551-03 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-479 | 42291-0479-30 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-480 | 42291-0480-30 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-481 | 42291-0481-30 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-482 | 42291-0482-30 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1248 | 00115-1248-0100115-1248-0300115-1248-08+1 more |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1249 | 00115-1249-0100115-1249-0300115-1249-08+1 more |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1250 | 00115-1250-0100115-1250-0300115-1250-08+1 more |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2577 | 69238-2577-0169238-2577-0269238-2577-03+1 more |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2578 | 69238-2578-0169238-2578-0269238-2578-03+1 more |
Other NDCs under ANDA 204717
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 | Amneal Pharmaceuticals NY LLC | 69238-2577 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2578 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2579 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals NY LLC | 69238-2580 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-479 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-480 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-481 |
| Carvedilol Phosphate | Carvedilol phosphate 80 mg/1 | Capsule, Extended releaseOral | AvKARE | 42291-482 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1248 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1249 |
| Carvedilol Phosphate | Carvedilol phosphate 40 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1250 |