FeraBright
- Product NDC
- 24338-310
- 11-digit product format
- 243380310
- Labeler code
- 24338
- Product ID
- 24338-310_ac5e7507-8e66-4da5-abd9-75ae80369b9f
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ferumoxytol
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Azurity Pharmaceuticals, Inc.
- Application
- NDA219868
- Marketing category
- NDA
- Marketing start
- 2025-10-20
- Substance
- FERUMOXYTOL
- Active strength
- 30 mg/mL
- Pharmacologic classes
- Iron [CS], Parenteral Iron Replacement [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- FeraBright
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FERUMOXYTOL | 30 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | R8DG7T2D3A |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 24338-310-10 | FeraBright | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION | 10 | | 2 |
| 24338-310-10 | FeraBright | 1 in 1 CARTON | INJECTION | 1 | | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 24338-310-10 | 24338031010 | 1 VIAL, SINGLE-DOSE in 1 CARTON (24338-310-10) / 10 mL in 1 VIAL, SINGLE-DOSE | 2025-10-20 | No | No | Current |