Prescription drug · ANDA
Carvedilol NDC 71335-2101
Carvedilol 6.25 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-2101-1 | 7133521010171335210101 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-2101-1)Marketed from Apr 3, 2024 | |
| 71335-2101-2 | 7133521010271335210102 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-2101-2)Marketed from Jul 14, 2022 | |
| 71335-2101-3 | 7133521010371335210103 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-2101-3)Marketed from Jul 21, 2022 | |
| 71335-2101-4 | 7133521010471335210104 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-2101-4)Marketed from Nov 17, 2023 | |
| 71335-2101-5 | 7133521010571335210105 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-2101-5)Marketed from Feb 12, 2024 | |
| 71335-2101-6 | 7133521010671335210106 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-2101-6)Marketed from Jul 8, 2022 | |
| 71335-2101-7 | 7133521010771335210107 | 25 TABLET, FILM COATED in 1 BOTTLE (71335-2101-7)Marketed from Apr 3, 2024 | |
| 71335-2101-8 | 7133521010871335210108 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-2101-8)Marketed from Apr 3, 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 — 6.25 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 077614
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 71335-2101_2f981ba4-8093-4e6c-b57a-dbc814213152SPL ID 2f981ba4-8093-4e6c-b57a-dbc814213152SPL set ID da830b08-1cdd-4d36-a068-c376fd7763c4RxCUI 200031UNII 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
N471335210101followed by a unit qualifier and the quantityPackage 71335-2101-01. 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 tablets 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 tablets 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 Myocardial Infarction Carvedilol tablets are indicated …
Excerpt only. Read the full label for complete information.
About NDC 71335-2101
- What is NDC 71335-2101?
- 71335-2101 is the product NDC for Carvedilol, Carvedilol 6.25 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 8 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 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 | NuCare Pharmaceuticals,Inc. | 68071-2780 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | St. Mary's Medical Park Pharmacy | 60760-582 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1826 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-411 |
| 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 | Bryant Ranch Prepack | 63629-4060 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 63629-4070 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Coupler LLC | 67046-0336 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-029 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-030 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-034 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1067 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-1062 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals, Inc. | 68071-3138 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-0840 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2230 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6878 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8252 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2389 |
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