Fludeoxyglucose F 18
- Product NDC
- 60055-334
- 11-digit product format
- 600550334
- Labeler code
- 60055
- Product ID
- 60055-334_7e9d26cc-5aee-4724-a5c5-535e70d234c5
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludeoxyglucose F-18
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Jubilant DraxImage Inc., dba Jubilant Radiopharma
- Application
- ANDA203920
- Marketing category
- ANDA
- Marketing start
- 2010-11-20
- 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 F 18
- 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#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 60055-334-30 | Fludeoxyglucose F 18 | 30 mL in 1 VIAL | INJECTION, SOLUTION | 30 | | 18 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Fludeoxyglucose F-18 | ACTIVE INGREDIENT | 0Z5B2CJX4D | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [TRIAD ISOTOPES, INC.] | 6 | |
| Fludeoxyglucose F-18 | ACTIVE MOIETY | 0Z5B2CJX4D | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [TRIAD ISOTOPES, INC.] | 6 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [TRIAD ISOTOPES, INC.] | 6 | |
| Sodium Chloride | INACTIVE INGREDIENT | 451W47IQ8X | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [TRIAD ISOTOPES, INC.] | 6 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [TRIAD ISOTOPES, INC.] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 60055-334 | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION, SOLUTION [JUBILANT DRAXIMAGE INC., DBA JUBILANT RADIOPHARMA] | 17 | Current NDC, Legacy NDC, 1 package rows | 20240112_5d05df4a-463e-4e66-9387-f3a842e20cd0.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 60055-334-30 | 60055033430 | 30 mL in 1 VIAL (60055-334-30) | 30 ml | 2015-09-01 | 0000-00-00 | No | No | Current |