Prescription drug · NDA
Venofer (iron sucrose) NDC 49230-534
Iron sucrose 20 mg/mL · Injection, Solution · Intravenous · Fresenius Medical Care Holdings, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 49230-534-10 | 49230053410 | 10 VIAL, SINGLE-DOSE in 1 BOX (49230-534-10) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)Marketed from Nov 4, 2008 | |
| 49230-534-25 | 49230053425 | 25 VIAL, SINGLE-DOSE in 1 TRAY (49230-534-25) / 5 mL in 1 VIAL, SINGLE-DOSE (49230-534-01)Marketed from Nov 4, 2008 |
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)
- Venofer
- Generic name (nonproprietary)
- iron sucrose
- Active ingredients
- Iron sucrose — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 021135
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 49230-534_e12cb876-ae80-416b-9bd3-a1cc83c9e666SPL ID e12cb876-ae80-416b-9bd3-a1cc83c9e666SPL set ID f1ab1a22-2b99-4d27-8b5a-9c3bcd5e3040RxCUI 1741267, 1741268, 1741270, 1741271UNII FZ7NYF5N8LUPC 0349230530254, 0349230534252
- 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
N449230053410followed by a unit qualifier and the quantityPackage 49230-0534-10. 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)
Venofer is indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD). Venofer 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 NDA 021135
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 |
|---|---|---|---|---|
| Venofer (Iron Sucrose) | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1568 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2310 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2325 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2340 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | Fresenius Medical Care Holdings, Inc. | 49230-530 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2340 |