Detectnet
- Product NDC
- 69945-064
- 11-digit product format
- 699450064
- Labeler code
- 69945
- Product ID
- 69945-064_2d08d179-39bb-5cd0-e063-6394a90a8ab0
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- copper Cu 64 Dotatate
- Dosage form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Labeler
- CURIUM US LLC
- Application
- NDA213227
- Marketing category
- NDA
- Marketing start
- 2020-09-14
- Substance
- COPPER OXODOTREOTIDE CU-64
- Active strength
- 1 mCi/mL
- Pharmacologic classes
- Positron Emitting Activity [MoA], Radioactive Diagnostic Agent [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Detectnet
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| COPPER OXODOTREOTIDE CU-64 | 1 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | N3858377KC |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69945-064-01 | Detectnet | 1 in 1 CAN | INJECTION, SOLUTION | 1 | | 5 |
| 69945-064-01 | Detectnet | 4 mL in 1 VIAL, SINGLE-USE | INJECTION, SOLUTION | 4 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69945-064 | DETECTNET (COPPER CU 64 DOTATATE) INJECTION, SOLUTION [CURIUM US LLC] | 5 | Current NDC, Legacy NDC, 2 package rows | 20250202_f898c8a7-beb7-4318-a8ea-6f058d69342b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69945-064-01 | 69945006401 | 1 VIAL, SINGLE-USE in 1 CAN (69945-064-01) / 4 mL in 1 VIAL, SINGLE-USE | 2020-09-14 | 0000-00-00 | No | No | Current |