Ioflupane I 123
- Product NDC
- 69945-166
- 11-digit product format
- 699450166
- Labeler code
- 69945
- Product ID
- 69945-166_c6a56613-3636-4736-bdaf-db89d8a8448b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- IOFLUPANE I-123
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Curium US LLC
- Application
- ANDA213792
- Marketing category
- ANDA
- Marketing start
- 2022-03-31
- Substance
- IOFLUPANE I-123
- Active strength
- 2 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
- Ioflupane I 123
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| IOFLUPANE I-123 | 2 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 3MM99T8R5Q |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69945-166-05 | Ioflupane I 123 | 2.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION | 2.5 | | 6 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69945-166 | IOFLUPANE I 123 (IOFLUPANE I-123) INJECTION, SOLUTION [CURIUM US LLC] | 6 | Current NDC, Legacy NDC, 1 package rows | 20221230_66d20aee-4530-48dd-a483-ed7604b36d97.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69945-166-05 | 69945016605 | 2.5 mL in 1 VIAL, SINGLE-DOSE (69945-166-05) | 2.5 ml | 2022-03-31 | 0000-00-00 | No | No | Current |