Sodium Fluoride F 18
- Product NDC
- 49609-102
- 11-digit product format
- 496090102
- Labeler code
- 49609
- Product ID
- 49609-102_31e5cd99-015b-86fa-e063-6394a90ad41b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM FLUORIDE F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- SOFIE Co.
- Application
- ANDA203592
- Marketing category
- ANDA
- Marketing start
- 2011-12-08
- 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 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 |
|---|
| 49609-102-01 | Sodium Fluoride F 18 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 8 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49609-102 | SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [SOFIE CO.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20250406_2bbd8f48-fdf9-45cb-8305-124a03f7a52c.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49609-102-01 | 49609010201 | 30 mL in 1 VIAL, MULTI-DOSE (49609-102-01) | 30 ml | 2011-12-08 | 0000-00-00 | No | No | Current |