Prescription drug · ANDA
Digoxin NDC 70954-202
Digoxin .25 mg/1 · Tablet · Oral · ANI Pharmaceuticals, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70954-202-10 | 7095402021070954020210 | 100 TABLET in 1 BOTTLE (70954-202-10)Marketed from Nov 22, 2021 | |
| 70954-202-20 | 7095402022070954020220 | 1000 TABLET in 1 BOTTLE (70954-202-20)Marketed from Nov 22, 2021 |
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/1
- Dosage form
- Tablet
- Route
- Oral
- Labeler
- ANI Pharmaceuticals, Inc.NDC labeler code 70954
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 215307
- Marketing start
- Listing expires
- Other FDA classes
- Cardiac Glycosides (Chemical structure)
- Identifiers
- Product ID 70954-202_ee465d1a-f5ee-477b-b20e-3ce8705e7472SPL ID ee465d1a-f5ee-477b-b20e-3ce8705e7472SPL set ID dba3b3f7-3ff2-4996-8653-b0e54a398bf9RxCUI 197604, 197606, 245273UNII 73K4184T59UPC 0370954201106, 0370954201205, 0370954202103, 0370954200109
- 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
N470954020210followed by a unit qualifier and the quantityPackage 70954-0202-10. 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 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 wit…
Excerpt only. Read the full label for complete information.
About NDC 70954-202
- What is NDC 70954-202?
- 70954-202 is the product NDC for Digoxin, Digoxin .25 mg/1 tablet, listed with the FDA by ANI Pharmaceuticals, Inc.. It has 2 package NDCs, 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?
- ANI Pharmaceuticals, Inc., NDC labeler code 70954. 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 215307
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 | Marlex Pharmaceuticals, Inc. | 10135-747 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | Marlex Pharmaceuticals, Inc. | 10135-748 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | Northwind Health Company, LLC | 51655-403 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | American Health Packaging | 60687-858 |
| Digoxin | Digoxin .25 mg/1 | TabletOral | American Health Packaging | 60687-869 |
| Digoxin | Digoxin .0625 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-200 |
| Digoxin | Digoxin .125 mg/1 | TabletOral | ANI Pharmaceuticals, Inc. | 70954-201 |