Fludeoxyglucose
- Product NDC
- 76451-118
- 11-digit product format
- 764510118
- Labeler code
- 76451
- Product ID
- 76451-118_47434382-85a5-899c-e063-6294a90ad8d9
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludeoxyglucose F18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- 3D Imaging Drug Design and Development LLC
- Application
- ANDA203778
- Marketing category
- ANDA
- Marketing start
- 2012-01-02
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Fludeoxyglucose
- Brand name suffix
- F18
- Listing expiration
- 2027-12-31
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#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 76451-118-10 | FludeoxyglucoseF18 | 10 mL in 1 VIAL, GLASS | INJECTION | 10 | | 3 |
| 76451-118-30 | FludeoxyglucoseF18 | 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 |
|---|
| 76451-118 | FLUDEOXYGLUCOSE F18 INJECTION [3D IMAGING DRUG DESIGN AND DEVELOPMENT LLC] | 1 | Current NDC, Legacy NDC, 2 package rows | 20190215_2785ce60-86c9-42c2-ab0a-8c5d5adf60d3.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 76451-118-10 | 76451011810 | 10 mL in 1 VIAL, GLASS (76451-118-10) | 10 ml | 2018-12-17 | 0000-00-00 | No | No | Current |
| 76451-118-11 | 76451011811 | 10 mL in 1 SYRINGE, PLASTIC (76451-118-11) | 10 ml | 2018-12-17 | 0000-00-00 | No | No | Current |
| 76451-118-30 | 76451011830 | 30 mL in 1 VIAL, GLASS (76451-118-30) | 30 ml | 2018-12-17 | 0000-00-00 | No | No | Current |
| 76451-118-51 | 76451011851 | 10 mL in 1 SYRINGE, PLASTIC (76451-118-51) | 10 ml | 2018-12-17 | 0000-00-00 | No | No | Current |