Prescription drug · NDA
Venofer (Iron sucrose) NDC 0517-2310
Iron sucrose 20 mg/mL · Injection, Solution · Intravenous · American Regent, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0517-2310-05 | 0051723100500517231005 | 5 VIAL, SINGLE-DOSE in 1 BOX (0517-2310-05) / 10 mL in 1 VIAL, SINGLE-DOSE (0517-2310-01)Marketed from Jun 12, 2007 |
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)
- Venofer
- Generic name (nonproprietary)
- iron sucrose
- Active ingredients
- Iron sucrose — 20 mg/mL
- Dosage form
- Injection, Solution
- Route
- Intravenous
- Labeler
- American Regent, Inc.NDC labeler code 0517
- 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 0517-2310_500b09f8-36f1-4842-8d07-246fea7bdfd0SPL ID 500b09f8-36f1-4842-8d07-246fea7bdfd0SPL set ID 626dc9e5-c6b4-4f9c-9bf4-774fd3ae619aRxCUI 1741261, 1741263, 1741267, 1741268, 1741270, 1741271UNII FZ7NYF5N8LUPC 0305172340016, 0305172340252
- 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
N400517231005followed by a unit qualifier and the quantityPackage 00517-2310-05. 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.
About NDC 0517-2310
- What is NDC 0517-2310?
- 0517-2310 is the product NDC for Venofer (iron sucrose), Iron sucrose 20 mg/mL injection, solution, listed with the FDA by American Regent, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Venofer (Iron sucrose).
- What is the active ingredient?
- Iron sucrose.
- Who is the labeler?
- American Regent, Inc., NDC labeler code 0517. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Venofer?
- 4 other product NDCs are listed under this name. See all Venofer NDCs.
- Is there a related HCPCS / J-code?
- Yes: J1756, Injection, iron sucrose, 1 mg. See Billing references above.
Related NDCs: other Venofer products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2325 | 00517-2325-10 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | Fresenius Medical Care Holdings, Inc. | 49230-530 | 49230-0530-1049230-0530-25 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | Fresenius Medical Care Holdings, Inc. | 49230-534 | 49230-0534-1049230-0534-25 |
| Venoferiron sucrose | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | American Regent, Inc. | 0517-2340 | 00517-2340-0100517-2340-1000517-2340-25 |
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 |
|---|---|---|---|---|
| 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 | Fresenius Medical Care Holdings, Inc. | 49230-534 |
| Venofer (Iron Sucrose) | Iron sucrose 20 mg/mL | Injection, SolutionIntravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1568 |