Prescription drug · ANDA
Iron Sucrose NDC 67457-639
Iron sucrose 200 mg/10mL · Injection, Solution · Intravenous · Mylan Institutional LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 67457-639-10 | 67457063910 | 5 VIAL, SINGLE-DOSE in 1 CARTON (67457-639-10) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 8, 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)
- Iron Sucrose
- Generic name (nonproprietary)
- iron sucrose
- Active ingredients
- Iron sucrose — 200 mg/10mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- Mylan Institutional LLC
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212559
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 67457-639_6ed21b25-9fbf-4a33-99e5-da98a4aa72bdSPL ID 6ed21b25-9fbf-4a33-99e5-da98a4aa72bdSPL set ID 3f109bdb-a412-43b2-84c7-9dad05e85a71RxCUI 1741261, 1741267, 1741270UNII FZ7NYF5N8L
- Pharmacologic class
- Parenteral Iron Replacement; Phosphate Binder
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 codeMed-Code curated
J1756 — Injection, iron sucrose, 1 mg
Billing unit: 1 mg. Units on the claim = dose given ÷ 1 mg.
- 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
N467457063910followed by a unit qualifier and the quantityPackage 67457-0639-10. 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)
Iron sucrose injection is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under ANDA 212559
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 |
|---|---|---|---|---|
| Iron Sucrose | Iron sucrose 100 mg/5mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-638 |
| Iron Sucrose | Iron sucrose 50 mg/2.5mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-957 |