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NDC 69488-0003-01 Lutathera 10 mCi/mL Details
Lutathera 10 mCi/mL
Lutathera is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Advanced Accelerator Applications USA, Inc. The primary component is LUTETIUM OXODOTREOTIDE LU-177.
Product Information
| NDC | 69488-0003 |
|---|---|
| Product ID | 69488-003_9bceadb5-9b6c-494d-af79-db912a16791b |
| Associated GPIs | 21600045202020 |
| GCN Sequence Number | 078110 |
| GCN Sequence Number Description | lutetium Lu 177 dotatate VIAL 10 MCI/ML INTRAVEN |
| HIC3 | V1G |
| HIC3 Description | RADIOACTIVE THERAPEUTIC AGENTS |
| GCN | 38973 |
| HICL Sequence Number | 044750 |
| HICL Sequence Number Description | LUTETIUM LU 177 DOTATATE |
| Brand/Generic | Brand |
| Proprietary Name | Lutathera |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Lutetium Lu 177 dotatate |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 10 |
| Active Ingredient Units | mCi/mL |
| Substance Name | LUTETIUM OXODOTREOTIDE LU-177 |
| Labeler Name | Advanced Accelerator Applications USA, Inc |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA208700 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 69488-0003-01 (69488000301)
| NDC Package Code | 69488-003-01 |
|---|---|
| Billing NDC | 69488000301 |
| Package | 1 VIAL in 1 PACKAGE (69488-003-01) / 20.5 mL in 1 VIAL |
| Marketing Start Date | 2018-01-26 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |