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 ID: 67457-991_07ab2fd4-cfe5-4cff-81bf-499602e5999c
• NDC: 67457-991
• Product Type: Human Prescription Drug
• Proprietary Name: OGIVRI
• Generic Name: Trastuzumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-11-29
• Marketing Category: BLA / BLA
• Application Number: BLA761074
• Labeler Name: Mylan Institutional LLC
• Substance Name: TRASTUZUMAB
• Active Ingredient Strength: 150 mg/7.4mL
• Pharm Classes: HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 67457-991-15

1 VIAL in 1 CARTON (67457-991-15) > 15 mL in 1 VIAL

• Marketing Start Date: 2019-11-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 67457-991-15 [67457099115]

OGIVRI INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761074
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-11-29

Drug Details

Pharmacological Class

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

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

NDC	Brand Name	Generic Name
67457-845	OGIVRI	trastuzumab
67457-847	OGIVRI	trastuzumab
67457-991	OGIVRI	trastuzumab
50242-132	Herceptin	Trastuzumab
50242-134	Herceptin	Trastuzumab
50242-333	Herceptin	Trastuzumab
63459-303	HERZUMA	TRASTUZUMAB
63459-305	HERZUMA	TRASTUZUMAB
0006-5033	Ontruzant	trastuzumab
0069-0305	Trazimera-qyyp	trastuzumab