Fluorescein
- Product NDC
- 54288-179
- 11-digit product format
- 542880179
- Labeler code
- 54288
- Product ID
- 54288-179_5b9c9100-13f7-4eab-a770-339aa885a949
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorescein
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- BPI Labs LLC
- Application
- ANDA220046
- Marketing category
- ANDA
- Marketing start
- 2026-05-20
- Substance
- FLUORESCEIN SODIUM
- Active strength
- 500 mg/5mL
- Pharmacologic classes
- Diagnostic Dye [EPC], Dyes [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluorescein
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUORESCEIN SODIUM | 500 mg/5mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 93X55PE38X |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 54288-179-01 | Fluorescein | 5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 5 | | 1 |
| 54288-179-10 | Fluorescein | 10 in 1 CARTON | INJECTION, SOLUTION | 10 | | 1 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 54288-179-01 | 54288017901 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |
| 54288-179-10 | 54288017910 | 10 VIAL, GLASS in 1 CARTON (54288-179-10) / 5 mL in 1 VIAL, GLASS (54288-179-01) | | 2026-05-20 | No | No | Historical |