Prescription drug · ANDA
Digoxin NDC 82685-201
Digoxin 125 ug/1 · Tablet · Oral · Oliva Therapeutics, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 82685-201-01 | 82685020101 | 100 TABLET in 1 BOTTLE (82685-201-01)Marketed from Sep 1, 2022 | |
| 82685-201-10 | 82685020110 | 1000 TABLET in 1 BOTTLE (82685-201-10)Marketed from Sep 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 — 125 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Oliva Therapeutics, LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 076268
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 82685-201_48481a34-0b24-a796-e063-6294a90af307SPL ID 48481a34-0b24-a796-e063-6294a90af307SPL set ID 5b2d10d0-6e9d-4c39-a025-6b2f30ff6243RxCUI 197604, 197606UNII 73K4184T59UPC 0382685202017, 0382685201010
- 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
N482685020101followed by a unit qualifier and the quantityPackage 82685-0201-01. 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 combinati…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 076268
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 250 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-3156 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Bryant Ranch Prepack | 72162-2268 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Bryant Ranch Prepack | 72162-2269 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Oliva Therapeutics, LLC | 82685-202 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2463 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2464 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Proficient Rx LP | 82804-244 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1991 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1992 |