FLUDEOXYGLUCOSE F-18
- Product NDC
- 78714-001
- 11-digit product format
- 787140001
- Labeler code
- 78714
- Product ID
- 78714-001_6862a859-c498-4540-aade-4f982e528fbe
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- FLUDEOXYGLUCOSE F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Barbara Ann Karmanos Cancer Hospital
- Application
- ANDA204385
- Marketing category
- ANDA
- Marketing start
- 2020-01-31
- Substance
- FLUDEOXYGLUCOSE F-18
- Active strength
- 300 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
- FLUDEOXYGLUCOSE F-18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUDEOXYGLUCOSE F-18 | 300 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 0Z5B2CJX4D |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 78714-001-30 | FLUDEOXYGLUCOSE F-18 | 30 mL in 1 VIAL, GLASS | INJECTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 78714-001 | FLUDEOXYGLUCOSE F-18 INJECTION [BARBARA ANN KARMANOS CANCER HOSPITAL] | 3 | Current NDC, Legacy NDC, 1 package rows | 20221122_e3791140-2e52-48c5-9849-536d5e4275e5.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 78714-001-30 | 78714000130 | 30 mL in 1 VIAL, GLASS (78714-001-30) | 30 ml | 2020-01-31 | 0000-00-00 | No | No | Current |