Prescription drug · NDA
Digoxin NDC 17856-0057
Digoxin .05 mg/mL · Solution · Oral · Atlantic Biologicals Corps
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 17856-0057-1 | 17856005701 | 2.5 mL in 1 CUP, UNIT-DOSE (17856-0057-1)Marketed from Dec 5, 2011 | |
| 17856-0057-5 | 17856005705 | 5 mL in 1 CUP (17856-0057-5)Marketed from Sep 24, 2018 |
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 — .05 mg/mL
- Dosage form
- Solution
- Route
- Oral
- Labeler
- Atlantic Biologicals Corps
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021648
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 17856-0057_45b28de4-8c3d-5d99-e063-6294a90a9a95SPL ID 45b28de4-8c3d-5d99-e063-6294a90a9a95SPL set ID dcf907d9-0f0e-4ecc-a555-7e6dcc08c166RxCUI 393245UNII 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
N417856005701followed by a unit qualifier and the quantityPackage 17856-0057-01. 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)
In adults, digoxin is indicated for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. (1) In pediatric patients with heart failure, digoxin increases myocardial contractility. 1.1 Heart Failure Digoxin Oral Solution, USP 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 increased exercise capacity and decreased 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-conv…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 021648
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 .05 mg/mL | SolutionOral | Hikma Pharmaceuticals USA Inc. | 0054-0057 |