Prescription drug · NDA
Digoxin NDC 0054-0057
Digoxin .05 mg/mL · Solution · Oral · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0054-0057-46 | 00054005746 | 60 mL in 1 BOTTLE (0054-0057-46)Marketed from Aug 26, 2004 |
How the 11-digit form is made: The labeler segment has 4 digits, so one leading zero is added to it (4-4-2 → 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 — .05 mg/mL
- Dosage form
- Solution
- Route
- Oral
- 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 0054-0057_db501397-8e41-4498-8626-49c6bfd79971SPL ID db501397-8e41-4498-8626-49c6bfd79971SPL set ID 1b7e5c6e-e052-41b0-a4ce-05dfe62faaafRxCUI 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
N400054005746followed by a unit qualifier and the quantityPackage 00054-0057-46. 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 in adults for the treatment of mild to moderate heart failure and for the control of resting ventricular rate in patients with chronic atrial fibrillation. ( 1.1 , 1.3 ) In pediatric patients with heart failure, digoxin is indicated to increase myocardial contractility. ( 1.2 ) 1.1 Heart Failure in Adults Digoxin Oral Solution 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, digox…
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 | Atlantic Biologicals Corps | 17856-0057 |