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NDC 00407-0691-62 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 | 00407-0691 |
|---|---|
| Product ID | 0407-0691_f1bbe198-bc8d-4a2b-9107-5c25e8cbf79a |
| Associated GPIs | 94500022202020 |
| GCN Sequence Number | 064088 |
| GCN Sequence Number Description | gadodiamide in 0.9 % NaCl SYRINGE 7.5MMOL/15 INTRAVEN |
| HIC3 | H1U |
| HIC3 Description | CEREBRAL SPINAL RADIOPAQUE DIAGNOSTICS |
| GCN | 99799 |
| HICL Sequence Number | 033212 |
| HICL Sequence Number Description | GADODIAMIDE IN 0.9 % SODIUM CHLORIDE |
| 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 | 2022-12-31 |
Package
NDC 00407-0691-62 (00407069162)
| NDC Package Code | 0407-0691-62 |
|---|---|
| Billing NDC | 00407069162 |
| Package | 10 SYRINGE, PLASTIC in 1 BOX (0407-0691-62) / 15 mL in 1 SYRINGE, PLASTIC |
| Marketing Start Date | 2006-09-21 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |