Prescription drug · ANDA
Digoxin NDC 69238-1991
Digoxin 125 ug/1 · Tablet · Oral · Amneal Pharmaceuticals NY LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 69238-1991-1 | 69238199101 | 100 TABLET in 1 BOTTLE (69238-1991-1)Marketed from Apr 1, 2019 | |
| 69238-1991-7 | 69238199107 | 1000 TABLET in 1 BOTTLE (69238-1991-7)Marketed from Apr 1, 2019 |
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
- 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 69238-1991_e9480117-8eb3-41e7-8928-1573d3d21d0eSPL ID e9480117-8eb3-41e7-8928-1573d3d21d0eSPL set ID f3d29508-e7cc-47ff-845d-b5375ee30407RxCUI 197604, 197606UNII 73K4184T59UPC 0369238199215, 0369238199116
- 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
N469238199101followed by a unit qualifier and the quantityPackage 69238-1991-01. 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)
INDICATIONS AND USAGE Heart Failure: Digoxin is indicated for the treatment of mild to moderate heart failure. Digoxin increases left ventricular ejection fraction and improves heart failure symptoms as evidenced by exercise capacity and heart failure symptoms as evidenced by exercise capacity and heart failure-related hospitalizations and emergency care, while having no effect on mortality. Where possible, digoxin should be used with a diuretic and an angiotensin-converting enzyme inhibitor, but an optimal order for starting these three drugs cannot be specified. Atrial Fibrillation: Digoxin is indicated for the control of ventricular response rate in patients with chronic atrial fibrillati…
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 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 250 ug/1 | TabletOral | Amneal Pharmaceuticals NY LLC | 69238-1992 |