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NDC 16129-0002-30 Sodium Fluoride 200 mCi/mL Details
Sodium Fluoride 200 mCi/mL
Sodium Fluoride is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Shertech Laboratories, LLC. The primary component is SODIUM FLUORIDE F-18.
Product Information
| NDC | 16129-0002 |
|---|---|
| Product ID | 16129-002_ceeffbf8-8a9b-fab7-e053-2995a90a8ae1 |
| Associated GPIs | |
| GCN Sequence Number | n/a |
| GCN Sequence Number Description | n/a |
| HIC3 | n/a |
| HIC3 Description | n/a |
| GCN | n/a |
| HICL Sequence Number | n/a |
| HICL Sequence Number Description | n/a |
| Brand/Generic | n/a |
| Proprietary Name | Sodium Fluoride |
| Proprietary Name Suffix | F 18 |
| Non-Proprietary Name | SODIUM FLUORIDE F 18 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 200 |
| Active Ingredient Units | mCi/mL |
| Substance Name | SODIUM FLUORIDE F-18 |
| Labeler Name | Shertech Laboratories, LLC |
| Pharmaceutical Class | Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA204315 |
| Listing Certified Through | 2022-12-31 |
Package
NDC 16129-0002-30 (16129000230)
| NDC Package Code | 16129-002-30 |
|---|---|
| Billing NDC | 16129000230 |
| Package | 30 mL in 1 VIAL, MULTI-DOSE (16129-002-30) |
| Marketing Start Date | 2011-03-23 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |