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NDC 00407-1414-98 Omnipaque 350 mg/mL Details
Omnipaque 350 mg/mL
Omnipaque is a INTRAVENOUS INJECTION, SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GE Healthcare. The primary component is IOHEXOL.
Product Information
| NDC | 00407-1414 |
|---|---|
| Product ID | 0407-1414_fc780ae9-6fd6-f433-e053-6394a90a1d9e |
| Associated GPIs | 94402042002040 94402042002044 |
| GCN Sequence Number | 000437 |
| GCN Sequence Number Description | iohexol INFUS. BTL 350 MG/ML INTRAVEN |
| HIC3 | A6U |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS-RADIOPAQUE |
| GCN | 25523 |
| HICL Sequence Number | 000151 |
| HICL Sequence Number Description | IOHEXOL |
| Brand/Generic | Brand |
| Proprietary Name | Omnipaque |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Iohexol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION, SOLUTION |
| Route | INTRAVENOUS |
| Active Ingredient Strength | 350 |
| Active Ingredient Units | mg/mL |
| Substance Name | IOHEXOL |
| Labeler Name | GE Healthcare |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020608 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00407-1414-98 (00407141498)
| NDC Package Code | 0407-1414-98 |
|---|---|
| Billing NDC | 00407141498 |
| Package | 10 BOTTLE, PLASTIC in 1 BOX (0407-1414-98) / 500 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2004-09-03 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |