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NDC 00019-1323-00 Optiray 678 mg/mL Details
Optiray 678 mg/mL
Optiray is a INTRA-ARTERIAL; INTRAVENOUS INJECTION in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Liebel-Flarsheim Company LLC. The primary component is IOVERSOL.
Product Information
| NDC | 00019-1323 |
|---|---|
| Product ID | 0019-1323_abc7573e-aa40-4f9a-8025-0f7f488bf0c7 |
| Associated GPIs | 94402055002068 |
| GCN Sequence Number | 016226 |
| GCN Sequence Number Description | ioversol SYRINGE 320 MG/ML INTRAVEN |
| HIC3 | A6U |
| HIC3 Description | CARDIOVASCULAR DIAGNOSTICS-RADIOPAQUE |
| GCN | 21581 |
| HICL Sequence Number | 004703 |
| HICL Sequence Number Description | IOVERSOL |
| Brand/Generic | Brand |
| Proprietary Name | Optiray |
| Proprietary Name Suffix | 320 |
| Non-Proprietary Name | Ioversol |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | INJECTION |
| Route | INTRA-ARTERIAL; INTRAVENOUS |
| Active Ingredient Strength | 678 |
| Active Ingredient Units | mg/mL |
| Substance Name | IOVERSOL |
| Labeler Name | Liebel-Flarsheim Company LLC |
| Pharmaceutical Class | Radiographic Contrast Agent [EPC], X-Ray Contrast Activity [MoA] |
| DEA Schedule | n/a |
| Marketing Category | NDA |
| Application Number | NDA020923 |
| Listing Certified Through | 2024-12-31 |
Package
NDC 00019-1323-00 (00019132300)
| NDC Package Code | 0019-1323-00 |
|---|---|
| Billing NDC | 00019132300 |
| Package | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1323-00) / 100 mL in 1 SYRINGE, PLASTIC |
| Marketing Start Date | 2012-03-04 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |