Prescription drug · NDA
Lanoxin (digoxin) NDC 70515-262
Digoxin 100 ug/mL · Injection, Solution · Intramuscular, Intravenous · Covis Pharma US, Inc
NDC codes
FDA NDC DirectoryProduct information
- Brand name (proprietary)
- Lanoxin
- Generic name (nonproprietary)
- digoxin
- Active ingredients
- Digoxin — 100 ug/mL
- Dosage form
- Injection, Solution
- Route
- Intramuscular, Intravenous
- Labeler
- Covis Pharma US, Inc
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 009330
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 70515-262_415f97e2-9ce0-b282-e063-6394a90ab0a8SPL ID 415f97e2-9ce0-b282-e063-6394a90ab0a8SPL set ID 9ec84cac-6ecc-43dc-8006-6ccc029e2707RxCUI 104208, 204504, 208135, 208137UNII 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 drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.
- Administration
Drug administration (CPT 96360–96549)
When a clinician administers the drug, the administration is reported separately. Codes in this range cover hydration, therapeutic injections and infusions, and chemotherapy or other complex drug administration. The right code depends on route, duration and drug type, and self-administered drugs are not billed this way.
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
LANOXIN 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 adults with chronic atrial fibrillation. ( 1.3 ) 1.1 Heart Failure in Adults LANOXIN is indicated for the treatment of mild to moderate heart failure in adults. LANOXIN 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, LANOXIN should be used in combination with a d…
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 009330
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 |
|---|---|---|---|---|
| Lanoxindigoxin | Digoxin 250 ug/mL | Injection, SolutionIntramuscular, Intravenous | Covis Pharma US, Inc | 70515-261 |
| Lanoxindigoxin | Digoxin 250 ug/mL | Injection, SolutionIntramuscular, Intravenous | Covis Pharma US, Inc | 70515-260 |
| Lanoxindigoxin | Digoxin 100 ug/mL | Injection, SolutionIntramuscular, Intravenous | Covis Pharma US, Inc | 70515-263 |