NDC 0407-0690
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 | 0407-0690_2a6abafc-4d41-4f23-9507-689793bbe9f4 |
| NDC | 0407-0690 |
| Product Type | Human Prescription Drug |
| Proprietary Name | OMNISCAN |
| Generic Name | Gadodiamide |
| Dosage Form | Injection |
| Route of Administration | INTRAVENOUS |
| Marketing Start Date | 2010-06-01 |
| 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 0407-0690-30
10 VIAL in 1 BOX (0407-0690-30) > 10 mL in 1 VIAL
| Marketing Start Date | 2010-06-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0407-0690-71 [00407069071]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA022066 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2007-10-02 |
| Marketing End Date | 2011-04-06 |
NDC 0407-0690-15 [00407069015]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-70 [00407069070]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA022066 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2007-10-02 |
NDC 0407-0690-22 [00407069022]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-10 [00407069010]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-20 [00407069020]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-17 [00407069017]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-43 [00407069043]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-0690-12 [00407069012]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-40 [00407069040]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-0690-05 [00407069005]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2002-04-19 |
NDC 0407-0690-55 [00407069055]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2002-04-19 |
| Marketing End Date | 2013-09-25 |
NDC 0407-0690-42 [00407069042]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-0690-30 [00407069030]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
NDC 0407-0690-50 [00407069050]
OMNISCAN INJECTION
| Marketing Category | NDA |
| Application Number | NDA020123 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2010-06-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| GADODIAMIDE | 287 mg/mL |
OpenFDA Data
| SPL SET ID: | f9fd4805-cbc1-4bc7-955f-e5cd4e1b03bb |
| Manufacturer | |
| UNII |
Pharmacological Class
- 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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