Prescription drug · ANDA
Carvedilol NDC 0904-7305
Carvedilol 3.125 mg/1 · Tablet, Film coated · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-7305-61 | 0090473056100904730561 | 100 BLISTER PACK in 1 CARTON (0904-7305-61) / 1 TABLET, FILM COATED in 1 BLISTER PACKMarketed from Jul 1, 2024 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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
- Major PharmaceuticalsNDC labeler code 0904
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078251
- Marketing start
- Listing expires
- Other FDA classes
- Adrenergic alpha-Antagonists (Mechanism)Adrenergic beta1-Antagonists (Mechanism)Adrenergic beta2-Antagonists (Mechanism)
- Identifiers
- Product ID 0904-7305_baec14b0-5683-4df3-a46f-6c53af96e9d8SPL ID baec14b0-5683-4df3-a46f-6c53af96e9d8SPL set ID ec6d8d73-9d18-4a9e-ae0c-0ea12059e78eRxCUI 200031, 200032, 200033, 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
N400904730561followed by a unit qualifier and the quantityPackage 00904-7305-61. 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 in…
Excerpt only. Read the full label for complete information.
About NDC 0904-7305
- What is NDC 0904-7305?
- 0904-7305 is the product NDC for Carvedilol, Carvedilol 3.125 mg/1 tablet, film coated, listed with the FDA by Major Pharmaceuticals. It has 1 package NDC, 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?
- Major Pharmaceuticals, NDC labeler code 0904. 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 078251
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 | Major Pharmaceuticals | 0904-7306 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7307 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Major Pharmaceuticals | 0904-7308 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2119 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-2175 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-4898 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | A-S Medication Solutions | 50090-6865 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Northwind Health Company, LLC | 51655-033 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2640 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2641 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2648 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Cardinal Health 107, LLC | 55154-2649 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Proficient Rx LP | 63187-131 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Redpharm Drug | 67296-2298 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-2773 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | NuCare Pharmaceuticals,Inc. | 68071-4816 |
| Carvedilol | Carvedilol 3.125 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-162 |
| Carvedilol | Carvedilol 6.25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-163 |
| Carvedilol | Carvedilol 12.5 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-164 |
| Carvedilol | Carvedilol 25 mg/1 | Tablet, Film coatedOral | Glenmark Pharmaceuticals Inc., USA | 68462-165 |
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