Fludeoxyglucose F-18
- Product NDC
- 16129-001
- 11-digit product format
- 161290001
- Labeler code
- 16129
- Product ID
- 16129-001_f4d59ef8-294d-496d-ab37-6a2b1f09774b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Fludeoxyglucose F-18
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Pharmalogic South Carolina, LLC
- Application
- ANDA204264
- Marketing category
- ANDA
- Marketing start
- 2006-03-29
- Marketing end
- 2026-06-05
- Substance
- FLUDEOXYGLUCOSE F-18
- Active strength
- 300 mCi/mL
- Pharmacologic classes
- Radioactive Diagnostic Agent [EPC], Radiopharmaceutical Activity [MoA]
- NDC exclude flag
- No
- Current FDA listing
- Yes
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 16129-001-10 | Fludeoxyglucose F-18 | 10 mL in 1 VIAL, MULTI-DOSE | INJECTION | 10 | | 15 |
| 16129-001-30 | Fludeoxyglucose F-18 | 30 mL in 1 VIAL, MULTI-DOSE | INJECTION | 30 | | 15 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 16129-001 | FLUDEOXYGLUCOSE F-18 INJECTION [PHARMALOGIC SOUTH CAROLINA, LLC] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240405_3535020f-26c3-40b8-bdb5-1aaa1857ba57.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 16129-001-10 | 16129000110 | 10 mL in 1 VIAL, MULTI-DOSE (16129-001-10) | 10 ml | 2006-03-29 | 0000-00-00 | No | No | Current |
| 16129-001-30 | 16129000130 | 30 mL in 1 VIAL, MULTI-DOSE (16129-001-30) | 30 ml | 2006-03-29 | 0000-00-00 | No | No | Current |