Sodium Fluoride F 18
- Product NDC
- 52670-550
- 11-digit product format
- 526700550
- Labeler code
- 52670
- Product ID
- 52670-550_46dfe08c-b98e-3f3b-e063-6394a90a5f60
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- sodium fluoride F 18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Mayo Clinic
- Application
- ANDA203605
- Marketing category
- ANDA
- Marketing start
- 2013-06-28
- Substance
- SODIUM FLUORIDE F-18
- Active strength
- 91.5 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 F 18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE F-18 | 91.5 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 |
|---|
| 52670-550-30 | Sodium Fluoride F 18 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 52670-550 | SODIUM FLUORIDE F 18 INJECTION [MAYO CLINIC] | 9 | Current NDC, Legacy NDC, 1 package rows | 20241219_e435568c-f8d2-4cee-aceb-c68b277ad8f5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 52670-550-30 | 52670055030 | 30 mL in 1 VIAL, MULTI-DOSE (52670-550-30) | 30 ml | 2013-06-28 | 0000-00-00 | No | No | Current |