NDC 0019-1332 – Optiray 300
Ioversol 636 mg/mL · Injection · Intra-arterial, Intravenous
Product NDC0019-1332
Product details
- Brand name
- Optiray 300
- Generic name
- Ioversol
- Labeler
- Liebel-Flarsheim Company LLC
- Dosage form
- Injection
- Route
- Intra-arterial, Intravenous
- Marketing category
- NDA · NDA019710
- Marketed since
- March 4, 2012
- Listing expires
- December 31, 2026
- Pharmacologic class
- Radiographic Contrast Agent
Active ingredients
- Ioversol 636 mg/mL
Package NDC codes (10)
| Package NDC | Description | Since |
|---|---|---|
| 0019-1332-00 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) / 100 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
| 0019-1332-06 | 25 BOTTLE, GLASS in 1 CARTON (0019-1332-06) / 50 mL in 1 BOTTLE, GLASS | Mar 4, 2012 |
| 0019-1332-11 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-11) / 100 mL in 1 BOTTLE, GLASS | Mar 4, 2012 |
| 0019-1332-16 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-16) / 150 mL in 1 BOTTLE, GLASS | Mar 4, 2012 |
| 0019-1332-21 | 12 BOTTLE, GLASS in 1 CARTON (0019-1332-21) / 200 mL in 1 BOTTLE, GLASS | Mar 4, 2012 |
| 0019-1332-75 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-75) / 50 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
| 0019-1332-78 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-78) / 50 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
| 0019-1332-83 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-83) / 100 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
| 0019-1332-90 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-90) / 100 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
| 0019-1332-91 | 20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-91) / 75 mL in 1 SYRINGE, PLASTIC | Mar 4, 2012 |
Recalls mentioning this NDC
- D-0773-2026 Aug 19, 2026 · Class I
Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass. - D-0137-2020 Oct 16, 2019 · Class II
Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syringe as expired and will not allow injection of product by the Optivantage injector.