NDC 0019-1332
Optiray 300
Ioversol
Optiray 300 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 | 0019-1332_0d687753-5c3f-47b3-921e-4c2f22ba6717 |
| NDC | 0019-1332 |
| Product Type | Human Prescription Drug |
| Proprietary Name | Optiray 300 |
| 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 | 636 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 0019-1332-00
20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) > 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 0019-1332-78 [00019133278]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-90 [00019133290]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-16 [00019133216]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-21 [00019133221]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-27 [00019133227]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
| Marketing End Date | 2012-03-16 |
NDC 0019-1332-00 [00019133200]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-75 [00019133275]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-83 [00019133283]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-11 [00019133211]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-06 [00019133206]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2012-03-04 |
NDC 0019-1332-61 [00019133261]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA020923 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Billing Unit | ML |
| Marketing Start Date | 2011-10-17 |
NDC 0019-1332-81 [00019133281]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
| Marketing End Date | 2012-03-16 |
NDC 0019-1332-91 [00019133291]
Optiray 300 INJECTION
| Marketing Category | NDA |
| Application Number | NDA019710 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 2012-03-04 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| IOVERSOL | 636 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 300" 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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