NDC codes

FDA NDC Directory
Product NDC (as listed)0781-3487Labeler and product segments. Claims need a package NDC.
Product NDC at billing width00781-3487Add 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 NDC11-digit (billing)PackageCopy
0781-3487-1400781348714007813487145 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-14) / 10 mL in 1 VIAL, SINGLE-DOSE (0781-3487-70)Marketed from Sep 22, 2025
0781-3487-92007813487920078134879210 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-92) / 10 mL in 1 VIAL, SINGLE-DOSEMarketed from Sep 22, 2025
0781-3487-9400781348794007813487941 VIAL, SINGLE-DOSE in 1 CARTON (0781-3487-94) / 10 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 — 200 mg/10mL
Dosage form
Injection
Route
Intravitreal
Labeler
Sandoz IncNDC labeler code 0781
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 0781-3487_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 codeNo match

No drug-specific HCPCS code in Med-Code's directory for this product. The directory is curated and not complete — check the current CMS HCPCS file before billing.

NDC on a medical claim

N400781348714 followed by a unit qualifier and the quantity

Package 00781-3487-14. 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.

Full label on DailyMed (opens in a new tab)

About NDC 0781-3487

What is NDC 0781-3487?
0781-3487 is the product NDC for Iron Sucrose, Iron sucrose 200 mg/10mL injection, listed with the FDA by Sandoz Inc. It has 3 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?
Sandoz Inc, NDC labeler code 0781. 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?
Not in Med-Code's curated HCPCS directory. See Billing references above.

Other finished products listed under the same name: strengths, forms and labelers.

Other Iron Sucrose NDCs
ProductStrengthForm · routeLabelerProduct NDCPackage NDCs (11-digit)
Iron SucroseIron sucrose 100 mg/5mLInjectionIntravenousSandoz Inc0781-348600781-3486-9500781-3486-96
Iron SucroseIron sucrose 50 mg/2.5mLInjectionIntravenousSandoz Inc0781-348500781-3485-9500781-3485-96
Iron SucroseIron sucrose 20 mg/mLInjectionIntravenousInternational Medication Systems, Limited76329-920276329-9202-05
Iron SucroseIron sucrose 20 mg/mLInjectionIntravenousInternational Medication Systems, Limited76329-920176329-9201-0176329-9201-05
Iron SucroseIron sucrose 20 mg/mLInjectionIntravenousInternational Medication Systems, Limited76329-920076329-9200-01
Iron SucroseIron sucrose 100 mg/5mLInjection, SolutionIntravenousMylan Institutional LLC67457-63867457-0638-1067457-0638-25
Iron SucroseIron sucrose 200 mg/10mLInjection, SolutionIntravenousMylan Institutional LLC67457-63967457-0639-10
Iron SucroseIron sucrose 50 mg/2.5mLInjection, SolutionIntravenousMylan Institutional LLC67457-95767457-0957-99

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
ProductStrengthForm · routeLabelerProduct NDC
Iron SucroseIron sucrose 50 mg/2.5mLInjectionIntravenousSandoz Inc0781-3485
Iron SucroseIron sucrose 100 mg/5mLInjectionIntravenousSandoz Inc0781-3486

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