Prescription drug · ANDA
Carvedilol NDC 65841-616
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Zydus Lifesciences Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 65841-616-01 | 65841061601 | 100 TABLET, FILM COATED in 1 BOTTLE (65841-616-01)Marketed from Sep 5, 2007 | |
| 65841-616-05 | 65841061605 | 500 TABLET, FILM COATED in 1 BOTTLE (65841-616-05)Marketed from Sep 5, 2007 | |
| 65841-616-17 | 65841061617 | 28 TABLET, FILM COATED in 1 BOTTLE (65841-616-17)Marketed from Sep 5, 2007 |
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 — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Zydus Lifesciences LimitedNDC labeler code 65841
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077614
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 65841-616_98f78a02-849a-4540-85f8-f0ea1eb1f8f1SPL ID 98f78a02-849a-4540-85f8-f0ea1eb1f8f1SPL set ID 29082d8c-bbde-4620-924f-02dcf1764919RxCUI 200031, 200032, 200033, 686924UNII 0K47UL67F2UPC 0368382092014, 0368382093011, 0368382094018
- 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
N465841061601followed by a unit qualifier and the quantityPackage 65841-0616-01. 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 .
About NDC 65841-616
- What is NDC 65841-616?
- 65841-616 is the product NDC for Carvedilol, Carvedilol 3.125 mg/1 tablet, film coated, listed with the FDA by Zydus Lifesciences Limited. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Carvedilol.
- What is the active ingredient?
- Carvedilol.
- Who is the labeler?
- Zydus Lifesciences Limited, NDC labeler code 65841. 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?
- 168 other product NDCs are listed under this name. See all Carvedilol NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Carvedilol 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 | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-690 | 72189-0690-90 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0973 | 67046-0973-03 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0879 | 67046-0879-03 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0336 | 67046-0336-03 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-664 | 72189-0664-60 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-663 | 72189-0663-90 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-653 | 72189-0653-90 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1616 | 67046-1616-03 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-499 | 72888-0499-0172888-0499-0272888-0499-03 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-502 | 72888-0502-0172888-0502-0272888-0502-03 |
Other NDCs under ANDA 077614
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 | Quallent Pharmaceuticals Health LLC | 82009-126 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-127 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-128 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4956 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6949 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-397 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4171 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-494 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-619 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-570 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-617 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Zydus Lifesciences Limited | 65841-618 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2780 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-125 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1826 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-582 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0356 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0426 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | QPharma Inc | 42708-181 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-029 |
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