NDC 0270-1316

ISOVUE 370

Iopamidol

ISOVUE 370 is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Bracco Diagnostics Inc. The primary component is Iopamidol.

Product ID0270-1316_01b4c288-3a85-406e-9c0a-bc801f85ed52
NDC0270-1316
Product TypeHuman Prescription Drug
Proprietary NameISOVUE 370
Generic NameIopamidol
Dosage FormInjection, Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2014-06-20
Marketing CategoryNDA / NDA
Application NumberNDA020327
Labeler NameBracco Diagnostics Inc
Substance NameIOPAMIDOL
Active Ingredient Strength755 mg/mL
Pharm ClassesRadiographic Contrast Agent [EPC],X-Ray Contrast Activity [MoA]
NDC Exclude FlagN
Listing Certified Through2021-12-31

Packaging

NDC 0270-1316-45

10 BOTTLE in 1 BOX (0270-1316-45) > 200 mL in 1 BOTTLE
Marketing Start Date2014-06-20
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 0270-1316-47 [00270131647]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1985-12-31
Marketing End Date2011-09-29

NDC 0270-1316-52 [00270131652]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31

NDC 0270-1316-44 [00270131644]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1985-12-31
Marketing End Date2011-09-29

NDC 0270-1316-45 [00270131645]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-06-20

NDC 0270-1316-95 [00270131695]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date2014-06-20

NDC 0270-1316-01 [00270131601]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31
Marketing End Date2016-12-31

NDC 0270-1316-40 [00270131640]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1985-12-31
Marketing End Date2011-09-29

NDC 0270-1316-04 [00270131604]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31

NDC 0270-1316-98 [00270131698]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-10-12

NDC 0270-1316-35 [00270131635]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31

NDC 0270-1316-37 [00270131637]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31

NDC 0270-1316-41 [00270131641]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA020327
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1994-10-12

NDC 0270-1316-30 [00270131630]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitML
Marketing Start Date1985-12-31

NDC 0270-1316-07 [00270131607]

ISOVUE 370 INJECTION, SOLUTION
Marketing CategoryNDA
Application NumberNDA018735
Product TypeHUMAN PRESCRIPTION DRUG
Marketing Start Date1985-12-31
Marketing End Date2011-09-29

Drug Details

Active Ingredients

IngredientStrength
IOPAMIDOL755 mg/mL

OpenFDA Data

SPL SET ID:797a11d7-dcd4-43ff-311b-3b48a10da2f2
Manufacturer
UNII

Pharmacological Class

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

NDC Crossover Matching brand name "ISOVUE 370" or generic name "Iopamidol"

NDCBrand NameGeneric Name
76381-316ISOVUE 370ISOVUE 370
0270-1314ISOVUEIOPAMIDOL
0270-1315ISOVUEIOPAMIDOL
0270-1316ISOVUEIOPAMIDOL
0270-1317ISOVUEIOPAMIDOL

Trademark Results [ISOVUE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ISOVUE
ISOVUE
85423219 4243227 Dead/Cancelled
Centrix, Inc.
2011-09-15
ISOVUE
ISOVUE
75239760 2132582 Dead/Cancelled
BRACCO DIAGNOSTICS, INC.
1997-02-07
ISOVUE
ISOVUE
73299442 1237972 Live/Registered
E. R. Squibb & Sons, Inc.
1981-02-25

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