Lutathera
- Product NDC
- 69488-003
- 11-digit product format
- 694880003
- Labeler code
- 69488
- Product ID
- 69488-003_74d44dec-f079-43b7-94ac-989a948f53ec
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Lutetium Lu 177 dotatate
- Dosage form
- INJECTION
- Route
- INTRAVENOUS
- Labeler
- Advanced Accelerator Applications USA, Inc
- Application
- NDA208700
- Marketing category
- NDA
- Marketing start
- 2018-01-26
- Substance
- LUTETIUM OXODOTREOTIDE LU-177
- Active strength
- 10 mCi/mL
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Lutathera
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| LUTETIUM OXODOTREOTIDE LU-177 | 10 mCi/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | AE221IM3BB |
| Rxcui | 1999682, 1999687 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 69488-003-01 | Lutathera | 1 in 1 PACKAGE | INJECTION | 1 | | 12 |
| 69488-003-01 | Lutathera | 20.5 mL in 1 VIAL | INJECTION | 20.5 | | 12 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 69488-003 | LUTATHERA (LUTETIUM LU 177 DOTATATE) INJECTION [ADVANCED ACCELERATOR APPLICATIONS USA, INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241213_72d1a024-00b7-418a-b36e-b2cb48f2ab55.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 69488-003-01 | 69488000301 | 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL | 1 vial | 2018-01-26 | 0000-00-00 | No | No | Current |