Prescription drug · ANDA
Carvedilol NDC 71335-1813
Carvedilol 12.5 mg/1 · Tablet, Film coated · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71335-1813-1 | 71335181301 | 30 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-1)Marketed from Jul 17, 2024 | |
| 71335-1813-2 | 71335181302 | 60 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-2)Marketed from Jun 11, 2021 | |
| 71335-1813-3 | 71335181303 | 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-3)Marketed from Sep 6, 2023 | |
| 71335-1813-4 | 71335181304 | 90 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-4)Marketed from Aug 10, 2021 | |
| 71335-1813-5 | 71335181305 | 120 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-5)Marketed from Jul 17, 2024 | |
| 71335-1813-6 | 71335181306 | 180 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-6)Marketed from Oct 27, 2021 | |
| 71335-1813-7 | 71335181307 | 10 TABLET, FILM COATED in 1 BOTTLE, PLASTIC (71335-1813-7)Marketed from Jul 17, 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 Prepack
- 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 71335-1813_20c68c68-b8ef-437c-8baa-878fcb2e0993SPL ID 20c68c68-b8ef-437c-8baa-878fcb2e0993SPL set ID 21191d89-16f6-49a8-9394-f31d0950deeaRxCUI 200032UNII 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
N471335181301followed by a unit qualifier and the quantityPackage 71335-1813-01. 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.
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 6.25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-943 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Golden State Medical Supply, Inc. | 51407-042 |
| 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 3.125 mg/1 | Tablet, Film coatedOral | Direct_Rx | 72189-653 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1407 |
| 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 |
| 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 | Proficient Rx LP | 82804-183 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-067 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-1457 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-5275 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Bryant Ranch Prepack | 71335-2474 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-713 |
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