Prescription drug · NDA
INFeD (iron dextran) NDC 0023-6082
Iron dextran 50 mg/mL · Injection · Intramuscular, Intravenous · Allergan, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0023-6082-10 | 00023608210 | 10 VIAL, SINGLE-DOSE in 1 CARTON (0023-6082-10) / 2 mL in 1 VIAL, SINGLE-DOSE (0023-6082-01)Marketed from Apr 29, 1974 |
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)
- INFeD
- Generic name (nonproprietary)
- iron dextran
- Active ingredients
- Iron dextran — 50 mg/mL
- Dosage form
- Injection
- Route
- Intramuscular, Intravenous
- Labeler
- Allergan, Inc.
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 017441
- Marketing start
- Listing expires
- Other FDA classes
- Iron (Chemical structure)Phosphate Chelating Activity (Mechanism)
- Identifiers
- Product ID 0023-6082_d6b2a709-570d-4ceb-8772-7961d247a42bSPL ID d6b2a709-570d-4ceb-8772-7961d247a42bSPL set ID 94b01b1e-794b-4bea-8e24-2e54683fc023RxCUI 206216, 311144UNII 95HR524N2M
- 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
N400023608210followed by a unit qualifier and the quantityPackage 00023-6082-10. 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 . This label includes a boxed warning.
Indications (excerpt from the label)
INFeD is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or have had an unsatisfactory response to oral iron. INFeD, an iron replacement product, is indicated for treatment of adult and pediatric patients of age 4 months and older with documented iron deficiency who have intolerance to oral iron or an unsatisfactory response to oral iron. ( 1 )
Excerpt only. Read the full label for complete information.
Other NDCs under NDA 017441
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 |
|---|---|---|---|---|
| Iron Dextran | Iron dextran 50 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1441 |
| Infediron dextran | Iron dextran 50 mg/mL | InjectionIntramuscular, Intravenous | Henry Schein, Inc. | 0404-9879 |