Prescription drug · ANDA
Digoxin NDC 0641-6184
Digoxin .25 mg/mL · Injection · Intramuscular, Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0641-6184-25 | 00641618425 | 25 AMPULE in 1 CARTON (0641-6184-25) / 2 mL in 1 AMPULE (0641-6184-01)Marketed from Oct 24, 1975 |
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 — .25 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 083391
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 0641-6184_df632d39-a158-45dc-81db-649b1be8a736SPL ID df632d39-a158-45dc-81db-649b1be8a736SPL set ID 9b9a4b3c-5f08-475a-a74d-0c7ebba40644RxCUI 104208UNII 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.
- NDC on a medical claim
N400641618425followed by a unit qualifier and the quantityPackage 00641-6184-25. 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 for: Treatment of mild to moderate heart failure in adults. ( 1.1 ) Control of resting ventricular rate in adults with chronic atrial fibrillation. ( 1.3 ) 1.1 Heart Failure in Adults Digoxin is indicated for the treatment of mild to moderate heart failure in adults. Digoxin 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, digoxin should be used in combination with a diuretic and an angiotensin-converting enzyme (ACE) inhibitor. 1.3 Atrial Fibrillation …
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 083391
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 .25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-1410 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1217 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | Cardinal Health 107, LLC | 55154-5106 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9850 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | ProPharma Distribution | 84549-410 |