DaTscan
- Product NDC
- 17156-210
- 11-digit product format
- 171560210
- Labeler code
- 17156
- Product ID
- 17156-210_900b7272-7f13-43ef-9320-bc63ccc1434b
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Ioflupane I-123
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- Medi-Physics Inc. dba GE Healthcare.
- Application
- NDA022454
- Marketing category
- NDA
- Marketing start
- 2011-03-01
- 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
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- DaTscan
- Listing expiration
- 2027-12-31
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 |
|---|
| 17156-210-01 | DaTscan | 1 in 1 CONTAINER | INJECTION, SOLUTION | 1 | | 17 |
| 17156-210-01 | DaTscan | 2.5 mL in 1 VIAL, GLASS | INJECTION, SOLUTION | 2.5 | | 17 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 17156-210 | DATSCAN (IOFLUPANE I-123) INJECTION, SOLUTION [MEDI-PHYSICS INC. DBA GE HEALTHCARE.] | 14 | Current NDC, Legacy NDC, 2 package rows | 20240112_ef7804d7-c691-495b-8aaf-5bc54fd5d9f6.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 17156-210-01 | 17156021001 | 1 VIAL, GLASS in 1 CONTAINER (17156-210-01) / 2.5 mL in 1 VIAL, GLASS | 2011-03-01 | 0000-00-00 | No | No | Current |