Prescription drug · NDA
Lanoxin (Digoxin) NDC 71610-019
Digoxin .125 mg/1 · Tablet · Oral · Aphena Pharma Solutions - Tennessee, LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 71610-019-60 | 7161000196071610001960 | 90 TABLET in 1 BOTTLE (71610-019-60)Marketed from Dec 8, 2017 |
How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 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)
- Lanoxin
- Generic name (nonproprietary)
- digoxin
- Active ingredients
- Digoxin — .125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Aphena Pharma Solutions - Tennessee, LLCNDC labeler code 71610
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020405
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 71610-019_1d7755ac-5480-4614-bc20-beb024ab95f2SPL ID 1d7755ac-5480-4614-bc20-beb024ab95f2SPL set ID f6c7ca21-1c76-4838-8fb9-e1bec6001d8bRxCUI 197604, 309888UNII 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
N471610001960followed by a unit qualifier and the quantityPackage 71610-0019-60. 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)
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 patients with chronic atrial fibrillation in adults. ( 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 combinati…
Excerpt only. Read the full label for complete information.
About NDC 71610-019
- What is NDC 71610-019?
- 71610-019 is the product NDC for Lanoxin (digoxin), Digoxin .125 mg/1 tablet, listed with the FDA by Aphena Pharma Solutions - Tennessee, LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Lanoxin (Digoxin).
- What is the active ingredient?
- Digoxin.
- Who is the labeler?
- Aphena Pharma Solutions - Tennessee, LLC, NDC labeler code 71610. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Lanoxin?
- 7 other product NDCs are listed under this name. See all Lanoxin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Lanoxin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Lanoxindigoxin | Digoxin 250 ug/mL | Injection, SolutionIntramuscular, Intravenous | Covis Pharma US, Inc | 70515-261 | 70515-0261-10 |
| Lanoxindigoxin | Digoxin 100 ug/mL | Injection, SolutionIntramuscular, Intravenous | Covis Pharma US, Inc | 70515-263 | 70515-0263-10 |
| 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 | 70515-262 | — |
| Lanoxindigoxin | Digoxin .0625 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-240 | 59212-0240-55 |
| Lanoxindigoxin | Digoxin .125 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-242 | 59212-0242-5559212-0242-56 |
| Lanoxindigoxin | Digoxin .25 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-249 | 59212-0249-55 |
Other NDCs under NDA 020405
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 .0625 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-240 |
| Lanoxindigoxin | Digoxin .125 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-242 |
| Lanoxindigoxin | Digoxin .25 mg/1 | TabletOral | Advanz Pharma (US) Corp. | 59212-249 |