Iron Sucrose NDC 0781-3485 · J-Code J1756

NDC codes

FDA NDC Directory

Product NDC (as listed)0781-3485Labeler and product segments. Claims need a package NDC.

Product NDC at billing width00781-3485Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
0781-3485-95	00781348595	10 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-95) / 2.5 mL in 1 VIAL, SINGLE-DOSE (0781-3485-56)Marketed from Sep 22, 2025
0781-3485-96	00781348596	25 VIAL, SINGLE-DOSE in 1 CARTON (0781-3485-96) / 2.5 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 — 50 mg/2.5mL
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: Sep 22, 2025
Listing expires: Dec 31, 2026
Other FDA classes: Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
Identifiers: Product ID 0781-3485_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.

How CPT relates to drug billing

NDC on a medical claim

N400781348595 followed by a unit qualifier and the quantity

Package 00781-3485-95. 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 Jun 30, 2025.

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.

Full label on DailyMed (opens in a new tab)

Other NDCs under ANDA 212340

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under ANDA 212340
Product	Strength	Form · route	Labeler	Product NDC
Iron Sucrose	Iron sucrose 100 mg/5mL	InjectionIntravenous	Sandoz Inc	0781-3486
Iron Sucrose	Iron sucrose 200 mg/10mL	InjectionIntravitreal	Sandoz Inc	0781-3487