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NDC 00407-2943-22 CLARISCAN 376.9 mg/mL Details
CLARISCAN 376.9 mg/mL
CLARISCAN is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GE Healthcare. The primary component is GADOTERATE MEGLUMINE.
Product Information
| NDC | 00407-2943 |
|---|---|
| Product ID | 0407-2943_d1cff6d2-eaf9-4e9f-9615-6ed0ceb7cd3a |
| Associated GPIs | 94500037102010 94500037102015 94500037102020 94500037102006 9450003710E510 9450003710E515 9450003710E520 94500037102040 |
| GCN Sequence Number | 071031 |
| GCN Sequence Number Description | gadoterate meglumine VIAL 5MMOL/10ML INTRAVEN |
| HIC3 | H1U |
| HIC3 Description | CEREBRAL SPINAL RADIOPAQUE DIAGNOSTICS |
| GCN | 34718 |
| HICL Sequence Number | 011774 |
| HICL Sequence Number Description | GADOTERATE MEGLUMINE |
| Brand/Generic | Generic |
| Proprietary Name | CLARISCAN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gadoterate meglumine |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 376.9 |
| Active Ingredient Units | mg/mL |
| Substance Name | GADOTERATE MEGLUMINE |
| Labeler Name | GE Healthcare |
| Pharmaceutical Class | Gadolinium-based Contrast Agent [EPC], Magnetic Resonance Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA210016 |
| Listing Certified Through | 2025-12-31 |
Package
NDC 00407-2943-22 (00407294322)
| NDC Package Code | 0407-2943-22 |
|---|---|
| Billing NDC | 00407294322 |
| Package | 10 SYRINGE, PLASTIC in 1 BOX (0407-2943-22) / 20 mL in 1 SYRINGE, PLASTIC |
| Marketing Start Date | 2020-11-16 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |