Prescription drug · ANDA
Sodium Ferric Gluconate Complex in Sucrose NDC 0143-9570
Sodium ferric gluconate complex 12.5 mg/mL · Injection · Intravenous · Hikma Pharmaceuticals USA Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0143-9570-10 | 0014395701000143957010 | 10 VIAL in 1 CARTON (0143-9570-10) / 5 mL in 1 VIAL (0143-9570-01)Marketed from Mar 31, 2011 |
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)
- Sodium Ferric Gluconate Complex in Sucrose
- Generic name (nonproprietary)
- sodium ferric gluconate complex in sucrose
- Active ingredients
- Sodium ferric gluconate complex — 12.5 mg/mL
- Dosage form
- Injection
- Route
- Intravenous
- Labeler
- Hikma Pharmaceuticals USA Inc.NDC labeler code 0143
- Product type
- Prescription drug
- Marketing category
- ANDA — Abbreviated New Drug Application (generic)Application ANDA 078215
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0143-9570_7a57fb1e-f803-4f81-a643-6fc18d8371ffSPL ID 7a57fb1e-f803-4f81-a643-6fc18d8371ffSPL set ID 218d1b8d-b24f-4f77-b588-97c7dd1c2eecRxCUI 242761UNII 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
N400143957010followed by a unit qualifier and the quantityPackage 00143-9570-10. 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)
Sodium ferric gluconate complex in sucrose injection 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. Sodium ferric gluconate complex in sucrose injection 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 0143-9570
- What is NDC 0143-9570?
- 0143-9570 is the product NDC for Sodium Ferric Gluconate Complex in Sucrose, Sodium ferric gluconate complex 12.5 mg/mL injection, listed with the FDA by Hikma Pharmaceuticals USA Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Sodium Ferric Gluconate Complex in Sucrose.
- What is the active ingredient?
- Sodium ferric gluconate complex.
- Who is the labeler?
- Hikma Pharmaceuticals USA Inc., NDC labeler code 0143. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Sodium Ferric Gluconate Complex in Sucrose?
- 1 other product NDC are listed under this name. See all Sodium Ferric Gluconate Complex in Sucrose NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Sodium Ferric Gluconate Complex in Sucrose products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Sodium Ferric Gluconate Complex in Sucrose | Sodium ferric gluconate complex 12.5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9298 | 00143-9298-10 |
Other NDCs under ANDA 078215
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 |
|---|---|---|---|---|
| Sodium Ferric Gluconate Complex in Sucrose | Sodium ferric gluconate complex 12.5 mg/mL | InjectionIntravenous | Hikma Pharmaceuticals USA Inc. | 0143-9298 |