NDC 67457-991

OGIVRI

Trastuzumab

OGIVRI is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Mylan Institutional Llc. The primary component is Trastuzumab.

Product ID67457-991_07ab2fd4-cfe5-4cff-81bf-499602e5999c
NDC67457-991
Product TypeHuman Prescription Drug
Proprietary NameOGIVRI
Generic NameTrastuzumab
Dosage FormInjection, Powder, Lyophilized, For Solution
Route of AdministrationINTRAVENOUS
Marketing Start Date2019-11-29
Marketing CategoryBLA / BLA
Application NumberBLA761074
Labeler NameMylan Institutional LLC
Substance NameTRASTUZUMAB
Active Ingredient Strength150 mg/7.4mL
Pharm ClassesHER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
NDC Exclude FlagN
Listing Certified Through2020-12-31

Packaging

NDC 67457-991-15

1 VIAL in 1 CARTON (67457-991-15) > 15 mL in 1 VIAL
Marketing Start Date2019-11-29
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 67457-991-15 [67457099115]

OGIVRI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Marketing CategoryBLA
Application NumberBLA761074
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2019-11-29

Drug Details

Pharmacological Class

  • HER2/neu Receptor Antagonist [EPC]
  • HER2/Neu/cerbB2 Antagonists [MoA]

NDC Crossover Matching brand name "OGIVRI" or generic name "Trastuzumab"

NDCBrand NameGeneric Name
67457-845OGIVRItrastuzumab
67457-847OGIVRItrastuzumab
67457-991OGIVRItrastuzumab
50242-132HerceptinTrastuzumab
50242-134HerceptinTrastuzumab
50242-333HerceptinTrastuzumab
63459-303HERZUMATRASTUZUMAB
63459-305HERZUMATRASTUZUMAB
0006-5033Ontruzanttrastuzumab
0069-0305Trazimera-qyyptrastuzumab

Trademark Results [OGIVRI]

Mark Image

Registration | Serial
Company
Trademark
Application Date
OGIVRI
OGIVRI
88650753 not registered Live/Pending
Mylan Institutional Inc.
2019-10-11
OGIVRI
OGIVRI
86970805 not registered Live/Pending
Mylan Institutional Inc.
2016-04-11

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