Sodium Fluoride
- Product NDC
- 81759-002
- 11-digit product format
- 817590002
- Labeler code
- 81759
- Product ID
- 81759-002_0da6e293-9150-3146-e063-6394a90a0399
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM FLUORIDE F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- BAMF Health Inc.
- Application
- ANDA204328
- Marketing category
- ANDA
- Marketing start
- 2022-12-06
- 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 |
|---|
| 81759-002-30 | Sodium FluorideF 18 | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 20221027 |
| 81759-002-30 | Sodium FluorideF 18 | 1 in 1 CONTAINER | INJECTION | 1 | | 20221027 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81759-002 | SODIUM FLUORIDE F 18 (SODIUM FLUORIDE F-18) INJECTION [BAMF HEALTH INC.] | 20221027 | Current NDC, Legacy NDC, 2 package rows | 20231230_ef58c3cd-a922-c5fc-e053-2a95a90a9d74.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 81759-002-30 | 81759000230 | 1 VIAL, GLASS in 1 CONTAINER (81759-002-30) / 10 mL in 1 VIAL, GLASS | 2022-12-06 | 0000-00-00 | No | No | Current |