NDC 50242-132

Herceptin

Trastuzumab

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

• Product ID: 50242-132_23b49e45-e152-40c5-bbc9-be52fce667af
• NDC: 50242-132
• Product Type: Human Prescription Drug
• Proprietary Name: Herceptin
• Generic Name: Trastuzumab
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2017-02-10
• Marketing Category: BLA / BLA
• Application Number: BLA103792
• Labeler Name: Genentech, Inc.
• 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 50242-132-01

1 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-01) > 15 mL in 1 VIAL, SINGLE-DOSE

• Marketing Start Date: 2017-02-10
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 50242-132-10 [50242013210]

Herceptin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103792
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-03

NDC 50242-132-01 [50242013201]

Herceptin INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA103792
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2017-02-10

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB	150 mg/7.4mL

OpenFDA Data

• SPL SET ID: 492dbdb2-077e-4064-bff3-372d6af0a7a2
• Manufacturer:
  • Genentech, Inc.
• UNII:
  • P188ANX8CK
• RxNorm Concept Unique ID - RxCUI:
  • 1922509
  • 1922518
  • 1922512
  • 1922516
  • 806573
  • 806575

Pharmacological Class

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

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

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