Prescription drug · ANDA
Digoxin NDC 84549-410
Digoxin .25 mg/mL · Injection · Intramuscular, Intravenous · ProPharma Distribution
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 84549-410-35 | 8454904103584549041035 | 2 mL in 1 AMPULE (84549-410-35)Marketed from Dec 11, 2025 |
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)
- Digoxin
- Generic name (nonproprietary)
- digoxin
- Active ingredients
- Digoxin — .25 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- ProPharma DistributionNDC labeler code 84549
- 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 84549-410_45b0d1e0-d1f5-28f6-e063-6394a90aaa51SPL ID 45b0d1e0-d1f5-28f6-e063-6394a90aaa51SPL set ID 45b0d1e0-d1f6-28f6-e063-6394a90aaa51RxCUI 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
N484549041035followed by a unit qualifier and the quantityPackage 84549-0410-35. 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. ( 1.2 ) 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. 1.2 Atrial Fibrillation …
Excerpt only. Read the full label for complete information.
About NDC 84549-410
- What is NDC 84549-410?
- 84549-410 is the product NDC for Digoxin, Digoxin .25 mg/mL injection, listed with the FDA by ProPharma Distribution. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Digoxin.
- What is the active ingredient?
- Digoxin.
- Who is the labeler?
- ProPharma Distribution, NDC labeler code 84549. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Digoxin?
- 50 other product NDCs are listed under this name. See all Digoxin NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Digoxin products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Digoxin | Digoxin .125 mg/1 | TabletOral | Coupler LLC | 67046-1317 | 67046-1317-03 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | American Health Packaging | 60687-869 | 60687-0869-01 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | American Health Packaging | 60687-858 | 60687-0858-01 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | AvPAK | 50268-238 | 50268-0238-15 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3859 | 70518-3859-00 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3860 | 70518-3860-00 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-403 | 51655-0403-52 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2463 | 71335-2463-0171335-2463-02 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-2464 | 71335-2464-0171335-2464-02 |
| Digoxin | Digoxin 250 ug/1 | TabletOral | Bryant Ranch Prepack | 71335-3156 | 71335-3156-0171335-3156-0271335-3156-03+1 more |
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 | Henry Schein, Inc. | 0404-9850 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-1410 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | Hikma Pharmaceuticals USA Inc. | 0641-6184 |
| 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 |