Prescription drug · ANDA
Iron Sucrose NDC 0781-3486
Iron sucrose 100 mg/5mL · Injection · Intravenous · Sandoz Inc
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0781-3486-95 | 00781348695 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-95) / 5 mL in 1 VIAL, SINGLE-DOSE (0781-3486-75)Marketed from Sep 22, 2025 | |
| 0781-3486-96 | 00781348696 | 25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3486-96) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 22, 2025 |
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)
- Iron Sucrose
- Generic name (nonproprietary)
- iron sucrose
- Active ingredients
- Iron sucrose — 100 mg/5mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Sandoz Inc
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 212340
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0781-3486_78c04f10-0489-4e45-8cb5-28a6789d1149SPL ID 78c04f10-0489-4e45-8cb5-28a6789d1149SPL set ID 78c04f10-0489-4e45-8cb5-28a6789d1149RxCUI 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
N400781348695followed by a unit qualifier and the quantityPackage 00781-3486-95. 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 212340
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 50 mg/2.5mL | InjectionIntravenous | Sandoz Inc | 0781-3485 |
| Iron Sucrose | Iron sucrose 200 mg/10mL | InjectionIntravitreal | Sandoz Inc | 0781-3487 |