Sodium Fluoride
- Product NDC
- 16129-002
- 11-digit product format
- 161290002
- Labeler code
- 16129
- Product ID
- 16129-002_f03019d1-8dd7-db23-e053-2a95a90aa566
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- SODIUM FLUORIDE F 18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Shertech Laboratories, LLC
- Application
- ANDA204315
- Marketing category
- ANDA
- Marketing start
- 2011-03-23
- Marketing end
- 0000-00-00
- 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
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 16129-002-10 | 16129000210 | 10 mL in 1 VIAL, MULTI-DOSE (16129-002-10) | 10 ml | 2011-03-23 | 0000-00-00 | No | No | Current |
| 16129-002-30 | 16129000230 | 30 mL in 1 VIAL, MULTI-DOSE (16129-002-30) | 30 ml | 2011-03-23 | 0000-00-00 | No | No | Current |