Prescription drug · NDA
Lanoxin (Digoxin) NDC 59212-249
Digoxin .25 mg/1 · Tablet · Oral · Advanz Pharma (US) Corp.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 59212-249-55 | 5921202495559212024955 | 100 TABLET in 1 BOTTLE (59212-249-55)Marketed from Sep 30, 2012 |
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 — .25 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Advanz Pharma (US) Corp.NDC labeler code 59212
- 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 59212-249_3a39029f-2e63-4894-8a0d-45e122f5047bSPL ID 3a39029f-2e63-4894-8a0d-45e122f5047bSPL set ID d91e3646-4c63-4512-ab22-db39c085c4dcRxCUI 104206, 197604, 197606, 245273, 309888, 309889, 1441565, 1441567UNII 73K4184T59UPC 0359212240552, 0359212249555, 0359212242556
- 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
N459212024955followed by a unit qualifier and the quantityPackage 59212-0249-55. 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 59212-249
- What is NDC 59212-249?
- 59212-249 is the product NDC for Lanoxin (digoxin), Digoxin .25 mg/1 tablet, listed with the FDA by Advanz Pharma (US) Corp.. 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?
- Advanz Pharma (US) Corp., NDC labeler code 59212. 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 .125 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-019 | 71610-0019-60 |
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 .125 mg/1 | TabletOral | Aphena Pharma Solutions - Tennessee, LLC | 71610-019 |