Prescription drug · NDA
Infed (Iron dextran) NDC 0404-9879
Iron dextran 50 mg/mL · Injection · Intramuscular, Intravenous · Henry Schein, Inc.
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 0404-9879-02 | 0040498790200404987902 | 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9879-02) / 2 mL in 1 VIAL, SINGLE-DOSEMarketed from Jan 11, 2022 |
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
- Henry Schein, Inc.NDC labeler code 0404
- 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 0404-9879_6dc448fd-d581-4cdb-a4a5-818a41f60c23SPL ID 6dc448fd-d581-4cdb-a4a5-818a41f60c23SPL set ID 99bf34be-cb8a-46d1-9637-5544dc2da287RxCUI 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
N400404987902followed by a unit qualifier and the quantityPackage 00404-9879-02. 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.
About NDC 0404-9879
- What is NDC 0404-9879?
- 0404-9879 is the product NDC for Infed (iron dextran), Iron dextran 50 mg/mL injection, listed with the FDA by Henry Schein, Inc.. It has 1 package NDC, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Infed (Iron dextran).
- What is the active ingredient?
- Iron dextran.
- Who is the labeler?
- Henry Schein, Inc., NDC labeler code 0404. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Infed?
- 1 other product NDC are listed under this name. See all Infed NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Infed products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| INFeDiron dextran | Iron dextran 50 mg/mL | InjectionIntramuscular, Intravenous | Allergan, Inc. | 0023-6082 | 00023-6082-10 |
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 |
|---|---|---|---|---|
| INFeDiron dextran | Iron dextran 50 mg/mL | InjectionIntramuscular, Intravenous | Allergan, Inc. | 0023-6082 |
| Iron Dextran | Iron dextran 50 mg/mL | InjectionIntramuscular, Intravenous | HF Acquisition Co LLC, DBA HealthFirst | 51662-1441 |