Fluorescein
- Product NDC
- 14789-122
- 11-digit product format
- 147890122
- Labeler code
- 14789
- Product ID
- 14789-122_b66b331e-c90a-48e0-9d9d-961c1cb5c9e2
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorescein
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Nexus Pharmaceuticals LLC
- Application
- ANDA215709
- Marketing category
- ANDA
- Marketing start
- 2023-10-24
- Substance
- FLUORESCEIN
- Active strength
- 500 mg/mL
- Pharmacologic classes
- Diagnostic Dye [EPC], Dyes [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluorescein
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUORESCEIN | 500 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | TPY09G7XIR |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 14789-122-05 | Fluorescein | 10 in 1 CARTON | INJECTION | 10 | | 5 |
| 14789-122-07 | Fluorescein | 5 mL in 1 VIAL | INJECTION | 5 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 14789-122 | FLUORESCEIN INJECTION [NEXUS PHARMACEUTICALS LLC] | 5 | Current NDC, 2 package rows | 20231026_0a2a65b1-dc88-445b-bfb7-53b2fd7bea2c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 14789-122-05 | 14789012205 | 10 VIAL in 1 CARTON (14789-122-05) / 5 mL in 1 VIAL (14789-122-07) | 10 vial | 2023-10-24 | No | No | Historical |
| 14789-122-07 | 14789012207 | 5 mL in 1 VIAL | 5 ml | | | | Historical |