Prescription drug · ANDA
Digoxin NDC 0904-5922
Digoxin 250 ug/1 · Tablet · Oral · Major Pharmaceuticals
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0904-5922-61 | 00904592261 | 100 BLISTER PACK in 1 CARTON (0904-5922-61) / 1 TABLET in 1 BLISTER PACKMarketed from Jun 10, 2009 |
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 — 250 ug/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- Major Pharmaceuticals
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 077002
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 0904-5922_fad1e8b6-cb2e-46de-8f64-22de878e8028SPL ID fad1e8b6-cb2e-46de-8f64-22de878e8028SPL set ID 48cad559-c17b-4d41-a154-e664e958c1c0RxCUI 197604, 197606UNII 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
N400904592261followed by a unit qualifier and the quantityPackage 00904-5922-61. 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 Tablets are 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 Digoxin Tablets are indicated for the treatment of mild to moderate heart failure in adults. Digoxin Tablets increase left ventricular ejection fraction and improve 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, Digox…
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 077002
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 125 ug/1 | TabletOral | NCS HealthCare of KY, LLC dba Vangard Labs | 0615-8202 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Major Pharmaceuticals | 0904-5921 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Golden State Medical Supply, Inc. | 60429-100 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1240 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Hikma Pharmaceuticals USA Inc. | 0143-1241 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Cardinal Health 107, LLC | 55154-5882 |