Prescription drug · ANDA
Digoxin NDC 10135-748
Digoxin .25 mg/1 · Tablet · Oral · Marlex Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 10135-748-01 | 10135074801 | 100 TABLET in 1 BOTTLE (10135-748-01)Marketed from Jun 1, 2022 | |
| 10135-748-10 | 10135074810 | 1000 TABLET in 1 BOTTLE (10135-748-10)Marketed from Jun 1, 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 — .25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Marlex Pharmaceuticals, Inc.
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215307
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 10135-748_40a9ac35-555b-4751-e063-6394a90a98aaSPL ID 40a9ac35-555b-4751-e063-6394a90a98aaSPL set ID e104c3c5-e4b8-7dbd-e053-2995a90ae339RxCUI 197604, 197606UNII 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
N410135074801followed by a unit qualifier and the quantityPackage 10135-0748-01. 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 is indicated for the treatment of mild to moderate heart failure in adults. Digoxin 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 should be used in combination wit…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 215307
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 | American Health Packaging | 60687-858 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | American Health Packaging | 60687-869 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-747 |
| Digoxin | Digoxin .0625 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-200 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-201 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-202 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-403 |