Prescription drug · ANDA
Iron Sucrose NDC 76329-9201
Iron sucrose 20 mg/mL · Injection · Intravenous · International Medication Systems, Limited
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 76329-9201-1 | 7632992010176329920101 | 10 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-1) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from Aug 12, 2025 | |
| 76329-9201-5 | 7632992010576329920105 | 20 VIAL, SINGLE-DOSE in 1 PACKAGE (76329-9201-5) / 5 mL in 1 VIAL, SINGLE-DOSEMarketed from May 11, 2026 |
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)
- Iron Sucrose
- Generic name (nonproprietary)
- iron sucrose
- Active ingredients
- Iron sucrose — 20 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- International Medication Systems, LimitedNDC labeler code 76329
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 208977
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 76329-9201_b9d702c5-5fca-4127-bf68-bb2ca6cc9192SPL ID b9d702c5-5fca-4127-bf68-bb2ca6cc9192SPL set ID 6f19c80e-22e9-4bab-aa53-4d2d958119edRxCUI 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
N476329920101followed by a unit qualifier and the quantityPackage 76329-9201-01. 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).
Excerpt only. Read the full label for complete information.
About NDC 76329-9201
- What is NDC 76329-9201?
- 76329-9201 is the product NDC for Iron Sucrose, Iron sucrose 20 mg/mL injection, listed with the FDA by International Medication Systems, Limited. It has 2 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Iron Sucrose.
- What is the active ingredient?
- Iron sucrose.
- Who is the labeler?
- International Medication Systems, Limited, NDC labeler code 76329. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Iron Sucrose?
- 8 other product NDCs are listed under this name. See all Iron Sucrose NDCs.
- Is there a related HCPCS / J-code?
- Yes: J1756, Injection, iron sucrose, 1 mg. See Billing references above.
Related NDCs: other Iron Sucrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Iron Sucrose | Iron sucrose 100 mg/5mL | InjectionIntravenous | Sandoz Inc | 0781-3486 | 00781-3486-9500781-3486-96 |
| Iron Sucrose | Iron sucrose 50 mg/2.5mL | InjectionIntravenous | Sandoz Inc | 0781-3485 | 00781-3485-9500781-3485-96 |
| Iron Sucrose | Iron sucrose 200 mg/10mL | InjectionIntravitreal | Sandoz Inc | 0781-3487 | 00781-3487-1400781-3487-9200781-3487-94 |
| Iron Sucrose | Iron sucrose 20 mg/mL | InjectionIntravenous | International Medication Systems, Limited | 76329-9202 | 76329-9202-05 |
| Iron Sucrose | Iron sucrose 20 mg/mL | InjectionIntravenous | International Medication Systems, Limited | 76329-9200 | 76329-9200-01 |
| Iron Sucrose | Iron sucrose 100 mg/5mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-638 | 67457-0638-1067457-0638-25 |
| Iron Sucrose | Iron sucrose 200 mg/10mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-639 | 67457-0639-10 |
| Iron Sucrose | Iron sucrose 50 mg/2.5mL | Injection, SolutionIntravenous | Mylan Institutional LLC | 67457-957 | 67457-0957-99 |
Other NDCs under ANDA 208977
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 20 mg/mL | InjectionIntravenous | International Medication Systems, Limited | 76329-9200 |
| Iron Sucrose | Iron sucrose 20 mg/mL | InjectionIntravenous | International Medication Systems, Limited | 76329-9202 |