Prescription drug · ANDA
Digoxin NDC 72162-2268
Digoxin 125 ug/1 · Tablet · Oral · Bryant Ranch Prepack
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 72162-2268-0 | 72162226800 | 1000 TABLET in 1 BOTTLE (72162-2268-0)Marketed from Feb 21, 2024 | |
| 72162-2268-1 | 72162226801 | 100 TABLET in 1 BOTTLE (72162-2268-1)Marketed from Feb 21, 2024 | |
| 72162-2268-2 | 72162226802 | 1000 TABLET in 1 BOTTLE (72162-2268-2)Marketed from Feb 21, 2024 | |
| 72162-2268-4 | 72162226804 | 100 TABLET in 1 BOTTLE (72162-2268-4)Marketed from Feb 21, 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)
- Digoxin
- Generic name (nonproprietary)
- digoxin
- Active ingredients
- Digoxin — 125 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Bryant Ranch Prepack
- 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 72162-2268_d3d58857-c095-44ef-8ff6-f4a2a5d781e1SPL ID d3d58857-c095-44ef-8ff6-f4a2a5d781e1SPL set ID e23bf2a6-1c24-44c4-8135-e469900f84b2RxCUI 197604UNII 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
N472162226800followed by a unit qualifier and the quantityPackage 72162-2268-00. 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 250 ug/1 | TabletOral | Bryant Ranch Prepack | 72162-2269 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Oliva Therapeutics, LLC | 82685-201 |
| 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 |