Fludeoxyglucose
- Product NDC
- 81759-001
- 11-digit product format
- 817590001
- Labeler code
- 81759
- Product ID
- 81759-001_347c6beb-499f-af61-e063-6394a90a6011
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludeoxyglucose F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- BAMF Health Inc.
- Application
- ANDA216125
- Marketing category
- ANDA
- Marketing start
- 2025-03-11
- Substance
- FLUDEOXYGLUCOSE F-18
- Active strength
- 400 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
- Brand name suffix
- F 18
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| FLUDEOXYGLUCOSE F-18 | 400 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 |
|---|
| 81759-001-30 | FludeoxyglucoseF 18 | 30 mL in 1 VIAL, GLASS | INJECTION | 30 | | 1 |
| 81759-001-30 | FludeoxyglucoseF 18 | 1 in 1 CONTAINER | INJECTION | 1 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 81759-001 | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION [BAMF HEALTH INC.] | 1 | Current NDC, 2 package rows | 20250514_347c6beb-499e-af61-e063-6394a90a6011.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 81759-001-30 | 81759000130 | 1 VIAL, GLASS in 1 CONTAINER (81759-001-30) / 30 mL in 1 VIAL, GLASS | 2025-03-11 | No | No | Current |