Prescription drug · ANDA
Carvedilol NDC 71335-1545
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1545-1 | 7133515450171335154501 | 30 TABLET, FILM COATED in 1 BOTTLE (71335-1545-1)Marketed from Mar 30, 2010 | |
| 71335-1545-2 | 7133515450271335154502 | 60 TABLET, FILM COATED in 1 BOTTLE (71335-1545-2)Marketed from Mar 30, 2010 | |
| 71335-1545-3 | 7133515450371335154503 | 100 TABLET, FILM COATED in 1 BOTTLE (71335-1545-3)Marketed from Mar 30, 2010 | |
| 71335-1545-4 | 7133515450471335154504 | 90 TABLET, FILM COATED in 1 BOTTLE (71335-1545-4)Marketed from Mar 30, 2010 | |
| 71335-1545-5 | 7133515450571335154505 | 120 TABLET, FILM COATED in 1 BOTTLE (71335-1545-5)Marketed from Mar 30, 2010 | |
| 71335-1545-6 | 7133515450671335154506 | 180 TABLET, FILM COATED in 1 BOTTLE (71335-1545-6)Marketed from Mar 30, 2010 | |
| 71335-1545-7 | 7133515450771335154507 | 10 TABLET, FILM COATED in 1 BOTTLE (71335-1545-7)Marketed from Apr 30, 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 — 12.5 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 71335-1545_35711bc7-16ba-4eb1-9ccc-b8e1bcf67ccdSPL ID 35711bc7-16ba-4eb1-9ccc-b8e1bcf67ccdSPL set ID 196536eb-8b94-45da-a2f3-f554d6bf88e9RxCUI 200032, 200033UNII 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
N471335154501followed by a unit qualifier and the quantityPackage 71335-1545-01. 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 71335-1545
- What is NDC 71335-1545?
- 71335-1545 is the product NDC for Carvedilol, Carvedilol 12.5 mg/1 tablet, film coated, listed with the FDA by Bryant Ranch Prepack. It has 7 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?
- 167 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 6.25 mg/1 | Tablet, Film coatedOral | Advagen Pharma Limited | 72888-500 | 72888-0500-0172888-0500-0272888-0500-03 |
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 12.5 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6878 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2101 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-2389 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-7786 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals Inc. | 68788-8252 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-663 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-128 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-125 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-5726 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-664 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-126 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Preferred Pharmaceuticals, Inc. | 68788-7539 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Quallent Pharmaceuticals Health LLC | 82009-127 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | PD-Rx Pharmaceuticals, Inc. | 72789-537 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-151 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | REMEDYREPACK INC. | 70518-1377 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-154 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-152 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | BluePoint Laboratories | 68001-153 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6949 |
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