Sodium Fluoride
- Product NDC
- 52768-125
- 11-digit product format
- 527680125
- Labeler code
- 52768
- Product ID
- 52768-125_2d6a7d5c-cf38-4ef7-b70b-86b58d37b905
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM FLUORIDE F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Precision Nuclear LLC
- Application
- ANDA204542
- Marketing category
- ANDA
- Marketing start
- 2011-01-01
- Substance
- SODIUM FLUORIDE F-18
- Active strength
- 200 mCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Sodium Fluoride
- Brand name suffix
- F 18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE F-18 | 200 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 9L75099X6R |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 52768-125-30 | Sodium FluorideF 18 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 8 |
| 52768-125-50 | Sodium FluorideF 18 | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION | 50 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52768-125 | SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [PRECISION NUCLEAR LLC] | 7 | Current NDC, Legacy NDC, 2 package rows | 20221224_d834721b-b624-4b27-9009-95e09827122e.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52768-125-30 | 52768012530 | 30 mL in 1 VIAL, MULTI-DOSE (52768-125-30) | 30 ml | 2011-01-01 | 0000-00-00 | No | No | Current |
| 52768-125-50 | 52768012550 | 50 mL in 1 VIAL, MULTI-DOSE (52768-125-50) | 50 ml | 2011-01-01 | 0000-00-00 | No | No | Current |