Fludeoxyglucose F 18
- Product NDC
- 49609-101
- 11-digit product format
- 496090101
- Labeler code
- 49609
- Product ID
- 49609-101_43f8e45a-9c5d-81fa-e063-6394a90acbf4
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludeoxyglucose F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- SOFIE Co.
- Application
- ANDA203591
- Marketing category
- ANDA
- Marketing start
- 2011-12-08
- 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 |
|---|
| 49609-101-01 | Fludeoxyglucose F 18 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 14 |
| 49609-101-02 | Fludeoxyglucose F 18 | 50 mL in 1 VIAL, MULTI-DOSE | INJECTION | 50 | | 14 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49609-101 | FLUDEOXYGLUCOSE F 18 (FLUDEOXYGLUCOSE F-18) INJECTION [SOFIE CO.] | 13 | Current NDC, Legacy NDC, 2 package rows | 20250406_2028be0c-333c-4e0c-be57-099276c725d7.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49609-101-01 | 49609010101 | 30 mL in 1 VIAL, MULTI-DOSE (49609-101-01) | 30 ml | 2011-12-08 | 0000-00-00 | No | No | Current |
| 49609-101-02 | 49609010102 | 50 mL in 1 VIAL, MULTI-DOSE (49609-101-02) | 50 ml | 2011-12-08 | 0000-00-00 | No | No | Current |