AK-FLUOR
- Product NDC
- 81298-8660
- 11-digit product format
- 812988660
- Labeler code
- 81298
- Product ID
- 81298-8660_ceefeb58-5c89-4157-a0bc-8a1409dc3873
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorescein
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Long Grove Pharmaceuticals, LLC
- Application
- NDA022186
- Marketing category
- NDA
- Marketing start
- 2024-09-28
- Substance
- FLUORESCEIN SODIUM
- Active strength
- 100 mg/mL
- 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
- AK-FLUOR
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUORESCEIN SODIUM | 100 mg/mL |
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 |
|---|
| 81298-8660-1 | AK-FLUOR | 5 mL in 1 VIAL, GLASS | INJECTION | 5 | | 4 |
| 81298-8660-3 | AK-FLUOR | 12 in 1 CARTON | INJECTION | 12 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81298-8660 | AK-FLUOR (FLUORESCEIN) INJECTION [LONG GROVE PHARMACEUTICALS, LLC] | 2 | Current NDC, 2 package rows | 20250316_73511e79-c050-4dc0-aa2f-a79ed320b5b0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 81298-8660-1 | 81298866001 | 5 mL in 1 VIAL, GLASS | 5 ml | | | | Historical |
| 81298-8660-3 | 81298866003 | 12 VIAL, GLASS in 1 CARTON (81298-8660-3) / 5 mL in 1 VIAL, GLASS (81298-8660-1) | | 2024-09-28 | No | No | Historical |