Prescription drug · ANDA
Carvedilol NDC 0615-8387
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · NCS HealthCare of KY, LLC dba Vangard Labs
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0615-8387-05 | 00615838705 | 15 TABLET, FILM COATED in 1 BLISTER PACK (0615-8387-05)Marketed from Aug 8, 2023 | |
| 0615-8387-39 | 00615838739 | 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8387-39)Marketed from Feb 23, 2021 |
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
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076373
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 0615-8387_d801a448-2fce-468f-8377-1271eeebba96SPL ID d801a448-2fce-468f-8377-1271eeebba96SPL set ID 2fb46fe1-9b7b-4718-9327-2471af22f0b7RxCUI 200031, 200032, 200033, 686924UNII 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
N400615838705followed by a unit qualifier and the quantityPackage 00615-8387-05. 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
Label details couldn’t be retrieved right now. Open the label on DailyMed.
Other NDCs under ANDA 076373
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 | Teva Pharmaceuticals USA, Inc. | 0093-0135 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-0051 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8388 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8389 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8390 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-138 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7890 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-191 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-225 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 82804-270 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7295 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Teva Pharmaceuticals USA, Inc. | 0093-7296 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | QPharma, Inc. | 42708-072 |