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 ID0019-1332_0d687753-5c3f-47b3-921e-4c2f22ba6717
NDC0019-1332
Product TypeHuman Prescription Drug
Proprietary NameOptiray 300
Generic NameIoversol
Dosage FormInjection
Route of AdministrationINTRA-ARTERIAL; INTRAVENOUS
Marketing Start Date2012-03-04
Marketing CategoryNDA / NDA
Application NumberNDA019710
Labeler NameLiebel-Flarsheim Company LLC
Substance NameIOVERSOL
Active Ingredient Strength636 mg/mL
Pharm ClassesRadiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 0019-1332-00

20 SYRINGE, PLASTIC in 1 CARTON (0019-1332-00) > 100 mL in 1 SYRINGE, PLASTIC
Marketing Start Date2012-03-04
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0019-1332-78 [00019133278]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-90 [00019133290]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-16 [00019133216]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-21 [00019133221]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-27 [00019133227]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-04
Marketing End Date2012-03-16

NDC 0019-1332-00 [00019133200]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-04

NDC 0019-1332-75 [00019133275]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-83 [00019133283]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-11 [00019133211]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-06 [00019133206]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2012-03-04

NDC 0019-1332-61 [00019133261]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA020923
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2011-10-17

NDC 0019-1332-81 [00019133281]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-04
Marketing End Date2012-03-16

NDC 0019-1332-91 [00019133291]

Optiray 300 INJECTION
Marketing CategoryNDA
Application NumberNDA019710
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date2012-03-04

Drug Details

Active Ingredients

IngredientStrength
IOVERSOL636 mg/mL

OpenFDA Data

SPL SET ID:549d38db-d4ed-4708-8f76-7cdaa157063f
Manufacturer
UNII
UPC Code
  • 0300191323873
  • 0300191324870
  • 0300191332905
  • 0300191333872
  • Pharmacological Class

    • Radiographic Contrast Agent [EPC]
    • X-Ray Contrast Activity [MoA]

    NDC Crossover Matching brand name "Optiray 300" or generic name "Ioversol"

    NDCBrand NameGeneric Name
    0019-1323OptirayIoversol
    0019-1324OptirayIoversol
    0019-1332OptirayIoversol
    0019-1333OptirayIoversol

    Trademark Results [Optiray]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    OPTIRAY
    OPTIRAY
    73710159 1526467 Live/Registered
    MALLINCKRODT, INC.
    1988-02-08

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