Prescription drug · ANDA
Carvedilol NDC 71335-1407
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1407-1 | 7133514070171335140701 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1407-1)Marketed from Dec 8, 2020 | |
| 71335-1407-2 | 7133514070271335140702 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1407-2)Marketed from Aug 19, 2021 | |
| 71335-1407-3 | 7133514070371335140703 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1407-3)Marketed from Sep 11, 2020 | |
| 71335-1407-4 | 7133514070471335140704 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1407-4)Marketed from Nov 22, 2019 | |
| 71335-1407-5 | 7133514070571335140705 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1407-5)Marketed from Nov 27, 2019 | |
| 71335-1407-6 | 7133514070671335140706 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1407-6)Marketed from Jul 9, 2024 |
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
- Generic name (nonproprietary)
- carvedilol
- Active ingredients
- Carvedilol — 3.125 mg/1
- Dosage form
- Tablet, Film coated
- Route
- Oral
- Labeler
- Bryant Ranch PrepackNDC labeler code 71335
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078384
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-1407_2bab4ad8-b8b9-4747-854d-4057779d27d2SPL ID 2bab4ad8-b8b9-4747-854d-4057779d27d2SPL set ID cc3a9614-3017-4775-988e-6e5bd4621b70RxCUI 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
N471335140701followed by a unit qualifier and the quantityPackage 71335-1407-01. 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 Tablet is 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 Tablets is 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 Myocardial Infarction Carvedilol Tablet is indicated to red…
Excerpt only. Read the full label for complete information.
About NDC 71335-1407
- What is NDC 71335-1407?
- 71335-1407 is the product NDC for Carvedilol, Carvedilol 3.125 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 6 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?
- Bryant Ranch Prepack, NDC labeler code 71335. 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?
- 169 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 12.5 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-501 | 72888-0501-0172888-0501-0272888-0501-03 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-499 | 72888-0499-0172888-0499-0272888-0499-03 |
Other NDCs under ANDA 078384
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 3.125 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-039 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-040 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-041 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-042 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-713 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-943 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-1616 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5275 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1457 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1813 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2474 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-062 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-063 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-066 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-067 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-653 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-110 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-111 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-112 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | UNICHEM PHARMACEUTICALS (USA), INC. | 76385-113 |
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