Prescription drug · ANDA
Digoxin NDC 59651-436
Digoxin .0625 mg/1 · Tablet · Oral · Aurobindo Pharma Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59651-436-01 | 59651043601 | 100 TABLET in 1 BOTTLE (59651-436-01)Marketed from Feb 8, 2022 | |
| 59651-436-99 | 59651043699 | 1000 TABLET in 1 BOTTLE (59651-436-99)Marketed from Feb 8, 2022 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Digoxin
- Generic name (nonproprietary)
- digoxin
- Active ingredients
- Digoxin — .0625 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aurobindo Pharma Limited
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214982
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 59651-436_1338ce78-5a23-4dd2-bb1b-335f35cb2646SPL ID 1338ce78-5a23-4dd2-bb1b-335f35cb2646SPL set ID 2bcd56ee-4497-4b8d-84db-a1470c77827bRxCUI 197604, 197606, 245273UNII 73K4184T59
- Pharmacologic class
- Cardiac Glycoside
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
N459651043601followed by a unit qualifier and the quantityPackage 59651-0436-01. 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)
Digoxin is a cardiac glycoside indicated for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Increasing myocardial contractility in pediatric patients with heart failure. ( 1.2 ) Control of resting ventricular rate in patients with chronic atrial fibrillation in adults. ( 1.3 ) 1.1 Heart Failure in Adults Digoxin tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin tablets increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by improved exercise capacity and decreased heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin tablets sh…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 214982
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 |
|---|---|---|---|---|
| Digoxin | Digoxin .125 mg/1 | TabletOral | Coupler LLC | 67046-1317 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7865 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | A-S Medication Solutions | 50090-6708 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3860 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3859 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-437 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-438 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | AvPAK | 50268-238 |