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NDC 00407-1416-12 OMNIPAQUE 12 mg/mL Details
OMNIPAQUE 12 mg/mL
OMNIPAQUE is a ORAL SOLUTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by GE Healthcare Inc.. The primary component is IOHEXOL.
Product Information
| NDC | 00407-1416 |
|---|---|
| Product ID | 0407-1416_9b00a600-5fce-4dd5-8db4-26248d46f0d9 |
| Associated GPIs | 94402042002063 |
| GCN Sequence Number | 078831 |
| GCN Sequence Number Description | iohexol SOLUTION 12 MG/ML ORAL |
| HIC3 | A6U |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS-RADIOPAQUE |
| GCN | 45227 |
| 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 | SOLUTION |
| Route | ORAL |
| Active Ingredient Strength | 12 |
| Active Ingredient Units | mg/mL |
| Substance Name | IOHEXOL |
| Labeler Name | GE Healthcare Inc. |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA018956 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00407-1416-12 (00407141612)
| NDC Package Code | 0407-1416-12 |
|---|---|
| Billing NDC | 00407141612 |
| Package | 10 BOTTLE, PLASTIC in 1 BOX (0407-1416-12) / 500 mL in 1 BOTTLE, PLASTIC |
| Marketing Start Date | 2018-04-27 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |