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NDC 00407-0690-40 OMNISCAN 287 mg/mL Details
OMNISCAN 287 mg/mL
OMNISCAN is a INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GE Healthcare Inc.. The primary component is GADODIAMIDE.
Product Information
| NDC | 00407-0690 |
|---|---|
| Product ID | 0407-0690_5ca2b122-b409-4e66-9378-b8b5e0ea999e |
| Associated GPIs | 94500022002020 94500022002025 |
| GCN Sequence Number | 064083 |
| GCN Sequence Number Description | gadodiamide VIAL 2.5MMOL/5 INTRAVEN |
| HIC3 | H1U |
| HIC3 Description | CEREBRAL SPINAL RADIOPAQUE DIAGNOSTICS |
| GCN | 99794 |
| HICL Sequence Number | 013188 |
| HICL Sequence Number Description | GADODIAMIDE |
| Brand/Generic | Brand |
| Proprietary Name | OMNISCAN |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | gadodiamide |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 287 |
| Active Ingredient Units | mg/mL |
| Substance Name | GADODIAMIDE |
| Labeler Name | GE Healthcare Inc. |
| Pharmaceutical Class | Magnetic Resonance Contrast Activity [MoA], Paramagnetic Contrast Agent [EPC] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00407-0690-40 (00407069040)
| NDC Package Code | 0407-0690-40 |
|---|---|
| Billing NDC | 00407069040 |
| Package | 10 VIAL in 1 BOX (0407-0690-40) / 15 mL in 1 VIAL |
| Marketing Start Date | 2010-06-01 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |