NDC 63459-303

HERZUMA

Trastuzumab

HERZUMA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Cephalon, Inc.. The primary component is Trastuzumab.

• Product ID: 63459-303_1319744e-b28e-4f84-80f7-388bb637f5db
• NDC: 63459-303
• Product Type: Human Prescription Drug
• Proprietary Name: HERZUMA
• Generic Name: Trastuzumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-05-16
• Marketing Category: BLA / BLA
• Application Number: BLA761091
• Labeler Name: Cephalon, Inc.
• Substance Name: TRASTUZUMAB
• Active Ingredient Strength: 150 mg/20mL
• Pharm Classes: HER2/neu Receptor Antagonist [EPC],HER2/Neu/cerbB2 Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 63459-303-43

1 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43) > 20 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2020-03-16
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 63459-303-43 [63459030343]

HERZUMA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761091
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2020-03-16

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB	150 mg/20mL

OpenFDA Data

• SPL SET ID: ae71c003-883a-4cd8-ad50-e8cc9a54e971
• Manufacturer:
  • Cephalon, Inc.
• UNII:
  • P188ANX8CK

Pharmacological Class

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

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

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