Prescription drug · ANDA
Digoxin NDC 70518-3859
Digoxin .125 mg/1 · Tablet · Oral · REMEDYREPACK INC.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70518-3859-0 | 7051838590070518385900 | 30 TABLET in 1 BLISTER PACK (70518-3859-0)Marketed from Sep 11, 2023 |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 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 — .125 mg/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- REMEDYREPACK INC.NDC labeler code 70518
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 214982
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 70518-3859_4d4c9ac6-3521-f5c8-e063-6294a90a57a7SPL ID 4d4c9ac6-3521-f5c8-e063-6294a90a57a7SPL set ID dbc0bc24-f250-47e8-8d10-6aef551823d7RxCUI 197604UNII 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
N470518385900followed by a unit qualifier and the quantityPackage 70518-3859-00. 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 ) 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 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 tablets sh…
Excerpt only. Read the full label for complete information.
About NDC 70518-3859
- What is NDC 70518-3859?
- 70518-3859 is the product NDC for Digoxin, Digoxin .125 mg/1 tablet, listed with the FDA by REMEDYREPACK 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?
- REMEDYREPACK INC., NDC labeler code 70518. 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 .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 |
| Digoxin | Digoxin 125 ug/1 | TabletOral | Bryant Ranch Prepack | 72162-2268 | 72162-2268-0072162-2268-0172162-2268-02+1 more |
Other NDCs under ANDA 214982
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 mg/1 | TabletOral | A-S Medication Solutions | 50090-6708 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | A-S Medication Solutions | 50090-7865 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | AvPAK | 50268-238 |
| Digoxin | Digoxin .0625 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-436 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-437 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | Aurobindo Pharma Limited | 59651-438 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Coupler LLC | 67046-1317 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | REMEDYREPACK INC. | 70518-3860 |