Prescription drug · NDA
Ferrlecit (Sodium ferric gluconate complex) NDC 0024-2794
Sodium ferric gluconate complex 12.5 mg/mL · Injection · Intravenous · sanofi-aventis U.S. LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0024-2794-10 | 00024279410 | 10 VIAL, SINGLE-USE in 1 CARTON (0024-2794-10) / 5 mL in 1 VIAL, SINGLE-USE (0024-2794-01)Marketed from Jul 7, 2014 |
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)
- Ferrlecit
- Generic name (nonproprietary)
- sodium ferric gluconate complex
- Active ingredients
- Sodium ferric gluconate complex — 12.5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- sanofi-aventis U.S. LLCNDC labeler code 0024
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 020955
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0024-2794_df1cd4cc-f035-435c-a17e-381071f0d9e1SPL ID df1cd4cc-f035-435c-a17e-381071f0d9e1SPL set ID b25b34ab-9cf1-4a2b-bdf2-5eaf66625999RxCUI 242761, 261123UNII CC9149U2QX
- 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.
- 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
N400024279410followed by a unit qualifier and the quantityPackage 00024-2794-10. 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)
Ferrlecit is indicated for the treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. Ferrlecit is an iron replacement product for treatment of iron deficiency anemia in adult patients and in pediatric patients age 6 years and older with chronic kidney disease receiving hemodialysis who are receiving supplemental epoetin therapy. ( 1 )
Excerpt only. Read the full label for complete information.
About NDC 0024-2794
- What is NDC 0024-2794?
- 0024-2794 is the product NDC for Ferrlecit (sodium ferric gluconate complex), Sodium ferric gluconate complex 12.5 mg/mL injection, listed with the FDA by sanofi-aventis U.S. LLC. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Ferrlecit (Sodium ferric gluconate complex).
- What is the active ingredient?
- Sodium ferric gluconate complex.
- Who is the labeler?
- sanofi-aventis U.S. LLC, NDC labeler code 0024. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Ferrlecit?
- 1 other product NDC are listed under this name. See all Ferrlecit NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Ferrlecit products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Ferrlecitsodium ferric gluconate complex | Sodium ferric gluconate complex 12.5 mg/mL | InjectionIntravenous | sanofi-aventis U.S. LLC | 0024-2792 | 00024-2792-10 |
Other NDCs under NDA 020955
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 |
|---|---|---|---|---|
| Ferrlecitsodium ferric gluconate complex | Sodium ferric gluconate complex 12.5 mg/mL | InjectionIntravenous | sanofi-aventis U.S. LLC | 0024-2792 |