Sodium Fluoride
- Product NDC
- 65857-300
- 11-digit product format
- 658570300
- Labeler code
- 65857
- Product ID
- 65857-300_56810233-d952-4904-a3e9-c3dc3aa480e6
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride F18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Cardinal Health 414, LLC
- Application
- ANDA203780
- Marketing category
- ANDA
- Marketing start
- 2015-07-30
- 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
- F18
- 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 |
|---|
| 65857-300-30 | Sodium FluorideF18 | 30 mL in 1 VIAL, GLASS | INJECTION | 30 | | 5 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65857-300 | SODIUM FLUORIDE F18 INJECTION [CARDINAL HEALTH 414, LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20181121_96e61ba1-30ca-4844-b503-056afd247e69.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65857-300-30 | 65857030030 | 30 mL in 1 VIAL, GLASS (65857-300-30) | 30 ml | 2015-07-30 | 0000-00-00 | No | No | Current |