Prescription drug · ANDA
Carvedilol Phosphate NDC 63629-9634
Carvedilol phosphate 40 mg/1 · Capsule, Extended release · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 63629-9634-1 | 6362996340163629963401 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9634-1)Marketed from May 11, 2023 | |
| 63629-9634-2 | 6362996340263629963402 | 90 CAPSULE, EXTENDED RELEASE in 1 BOTTLE, PLASTIC (63629-9634-2)Marketed from May 11, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — 40 mg/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 63629
- 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 63629-9634_15aeef75-db3f-4a52-9da7-4777349637afSPL ID 15aeef75-db3f-4a52-9da7-4777349637afSPL set ID cea10014-72b0-4190-a391-733c8912efe0RxCUI 860522UNII 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
N463629963401followed by a unit qualifier and the quantityPackage 63629-9634-01. 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
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.
About NDC 63629-9634
- What is NDC 63629-9634?
- 63629-9634 is the product NDC for Carvedilol Phosphate, Carvedilol phosphate 40 mg/1 capsule, extended release, listed with the FDA by Bryant Ranch Prepack. It has 2 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?
- Bryant Ranch Prepack, NDC labeler code 63629. 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 80 mg/1 | Capsule, Extended releaseOral | Amneal Pharmaceuticals of New York LLC | 0115-1251 | 00115-1251-0100115-1251-0300115-1251-08+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 |
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 | NorthStar RxLLC | 16714-227 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | NorthStar RxLLC | 16714-228 |
| 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 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 80 mg/1 | Capsule, Extended releaseOral | Golden State Medical Supply, Inc. | 51407-053 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Sun Pharmaceutical Industries, Inc. | 57664-663 |
| 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 | Sun Pharmaceutical Industries, Inc. | 57664-666 |
| 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 | Coupler LLC | 67046-1551 |
| Carvedilol Phosphate | Carvedilol phosphate 10 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-0308 |
| Carvedilol Phosphate | Carvedilol phosphate 20 mg/1 | Capsule, Extended releaseOral | Bryant Ranch Prepack | 71335-9707 |