FLUORESCITE
- Product NDC
- 0065-0092
- 11-digit product format
- 000650092
- Labeler code
- 0065
- Product ID
- 0065-0092_85861756-9727-4a43-8a4e-48564e341c48
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- fluorescein sodium
- Dosage form
- INJECTION, SOLUTION
- Route
- OPHTHALMIC
- Labeler
- Alcon, Inc.
- Application
- NDA021980
- Marketing category
- NDA
- Marketing start
- 1972-09-15
- Substance
- FLUORESCEIN SODIUM
- Active strength
- 100 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
- FLUORESCITE
- Listing expiration
- 2026-12-31
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 |
|---|
| 0065-0092-05 | FLUORESCITE | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 18 |
| 0065-0092-05 | FLUORESCITE | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 18 |
| 0065-0092-65 | FLUORESCITE | 5 mL in 1 VIAL | INJECTION, SOLUTION | 5 | | 18 |
| 0065-0092-65 | FLUORESCITE | 12 in 1 CARTON | INJECTION, SOLUTION | 12 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| FLUORESCEIN SODIUM | ACTIVE INGREDIENT | 93X55PE38X | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 6 | |
| FLUORESCEIN | ACTIVE MOIETY | TPY09G7XIR | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 6 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 6 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0065-0092 | FLUORESCITE (FLUORESCEIN SODIUM) INJECTION, SOLUTION [ALCON, INC.] | 18 | Current NDC, Legacy NDC, 4 package rows | 20231215_ebb3883c-71f6-4fd0-a7e6-0ba8e1136dd9.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 0065-0092-05 | 00065009205 | 12 in 1 CARTON | | | | | | Historical |
| 0065-0092-65 | 00065009265 | 12 VIAL in 1 CARTON (0065-0092-65) / 5 mL in 1 VIAL | 12 vial | 1972-09-15 | 0000-00-00 | No | No | Current |