NDC 0407-0691
OMNISCAN
Gadodiamide
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 ID | 0407-0691_9eb95474-c1d6-4970-b935-10d79280df5f |
| NDC | 0407-0691 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMNISCAN |
| Generic Name | Gadodiamide |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2006-09-21 |
| Marketing Category | NDA / NDA |
| Application Number | NDA020123 |
| Labeler Name | GE Healthcare Inc. |
| Substance Name | GADODIAMIDE |
| Active Ingredient Strength | 287 mg/mL |
| Pharm Classes | Magnetic Resonance Contrast Activity [MoA],Paramagnetic Contrast Agent [EPC] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0407-0691-62
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 |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-0691-64 [00407069164]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-07-29 |
| Marketing End Date | 2012-01-30 |
NDC 0407-0691-62 [00407069162]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-0691-63 [00407069163]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2006-09-21 |
NDC 0407-0691-65 [00407069165]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2005-07-29 |
| Marketing End Date | 2012-01-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADODIAMIDE | 287 mg/mL |
OpenFDA Data
| SPL SET ID: | 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a |
| Manufacturer | |
| UNII |
Pharmacological Class
- Magnetic Resonance Contrast Activity [MoA]
- Paramagnetic Contrast Agent [EPC]
- Magnetic Resonance Contrast Activity [MoA]
- Paramagnetic Contrast Agent [EPC]
NDC Crossover Matching brand name "OMNISCAN" or generic name "Gadodiamide"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0407-0690 | OMNISCAN | gadodiamide |
| 0407-0691 | OMNISCAN | gadodiamide |
Trademark Results [OMNISCAN]
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