Sodium Fluoride
- Product NDC
- 13267-542
- 11-digit product format
- 132670542
- Labeler code
- 13267
- Product ID
- 13267-542_2e4dae7b-58ec-4b60-bff5-a1ecf6147d18
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride F 18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
- Application
- ANDA204328
- Marketing category
- ANDA
- Marketing start
- 2014-11-19
- Substance
- SODIUM FLUORIDE F-18
- Active strength
- 600 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 | 600 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 |
|---|
| 13267-542-42 | Sodium FluorideF 18 | 20 mL in 1 VIAL, GLASS | INJECTION | 20 | | 20191111 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13267-542 | SODIUM FLUORIDE F 18 INJECTION [THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH] | 20191111 | Current NDC, Legacy NDC, 1 package rows | 20191123_f8afb06c-f4c3-46f0-8f8b-0bc9e072ce47.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13267-542-42 | 13267054242 | 20 mL in 1 VIAL, GLASS (13267-542-42) | 20 ml | 2014-11-19 | 0000-00-00 | No | No | Current |