Fluorodopa
- Product NDC
- 13267-346
- 11-digit product format
- 132670346
- Labeler code
- 13267
- Product ID
- 13267-346_f8d69c66-d9aa-4bb8-bb56-5bebeef87af5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fluorodopa F18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH
- Application
- NDA200655
- Marketing category
- NDA
- Marketing start
- 2019-10-10
- Substance
- FLUORODOPA F-18
- Active strength
- 40 mCi/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fluorodopa
- Brand name suffix
- F18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUORODOPA F-18 | 40 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 2C598205QX |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 13267-346-57 | FluorodopaF18 | 30 mL in 1 VIAL, GLASS | INJECTION | 30 | | 20210115 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 13267-346 | FLUORODOPA F18 INJECTION [THE FEINSTEIN INSTITUTES FOR MEDICAL RESEARCH] | 20210115 | Current NDC, Legacy NDC, 1 package rows | 20210116_37f8c405-ccb6-4fcd-8513-108956bb1674.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 13267-346-57 | 13267034657 | 30 mL in 1 VIAL, GLASS (13267-346-57) | 30 ml | 2019-10-10 | 0000-00-00 | No | No | Current |