NDC 0019-1333
Optiray 350
Ioversol
Optiray 350 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 ID | 0019-1333_0d687753-5c3f-47b3-921e-4c2f22ba6717 |
| NDC | 0019-1333 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Optiray 350 |
| Generic Name | Ioversol |
| Dosage Form | Injection |
| Route of Administration | INTRA-ARTERIAL; INTRAVENOUS |
| Marketing Start Date | 2012-03-04 |
| Marketing Category | NDA / NDA |
| Application Number | NDA019710 |
| Labeler Name | Liebel-Flarsheim Company LLC |
| Substance Name | IOVERSOL |
| Active Ingredient Strength | 741 mg/mL |
| Pharm Classes | Radiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA] |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 0019-1333-00
20 SYRINGE, PLASTIC in 1 CARTON (0019-1333-00) > 100 mL in 1 SYRINGE, PLASTIC
| Marketing Start Date | 2012-03-04 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 0019-1333-90 [00019133390]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-00 [00019133300]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-75 [00019133375]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-55 [00019133355]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-21 [00019133321]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-77 [00019133377]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-91 [00019133391]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-16 [00019133316]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-41 [00019133341]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
| Marketing End Date | 2016-03-07 |
NDC 0019-1333-85 [00019133385]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-95 [00019133395]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-87 [00019133387]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-27 [00019133327]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-51 [00019133351]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA020923 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-10-17 |
NDC 0019-1333-06 [00019133306]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-83 [00019133383]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-81 [00019133381]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-11 [00019133311]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-61 [00019133361]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA020923 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-10-17 |
NDC 0019-1333-78 [00019133378]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1333-52 [00019133352]
Optiray 350 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOVERSOL | 741 mg/mL |
OpenFDA Data
| SPL SET ID: | 549d38db-d4ed-4708-8f76-7cdaa157063f |
| Manufacturer | |
| UNII | |
| UPC Code |
Pharmacological Class
- Radiographic Contrast Agent [EPC]
- X-Ray Contrast Activity [MoA]
NDC Crossover Matching brand name "Optiray 350" or generic name "Ioversol"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 0019-1323 | Optiray | Ioversol |
| 0019-1324 | Optiray | Ioversol |
| 0019-1332 | Optiray | Ioversol |
| 0019-1333 | Optiray | Ioversol |
Trademark Results [Optiray]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OPTIRAY 73710159 1526467 Live/Registered |
MALLINCKRODT, INC. 1988-02-08 |
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