Prescription drug · ANDA
Digoxin NDC 0404-9850
Digoxin .25 mg/mL · Injection · Intramuscular, Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9850-02 | 0040498500200404985002 | 1 AMPULE in 1 BAG (0404-9850-02) / 2 mL in 1 AMPULEMarketed from Jan 10, 2022 |
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
- Labeler
- Henry Schein, Inc.NDC labeler code 0404
- 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 0404-9850_a8ec9757-c9a4-4b96-af0b-1689696766acSPL ID a8ec9757-c9a4-4b96-af0b-1689696766acSPL set ID 98d2ad5b-9ffa-4456-9a01-567636c3a4d2RxCUI 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
N400404985002followed by a unit qualifier and the quantityPackage 00404-9850-02. 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)
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 imporves heart failure symptoms, as evidenced by 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 in Adults Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. Digoxin is a cardiac…
Excerpt only. Read the full label for complete information.
About NDC 0404-9850
- What is NDC 0404-9850?
- 0404-9850 is the product NDC for Digoxin, Digoxin .25 mg/mL injection, listed with the FDA by Henry Schein, Inc.. 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?
- Henry Schein, Inc., NDC labeler code 0404. 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 | 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 |
| Digoxin | Digoxin .25 mg/mL | InjectionIntramuscular, Intravenous | ProPharma Distribution | 84549-410 |