NDC 55513-132

Kanjinti

Trastuzumab-anns

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

• Product ID: 55513-132_26beb717-cc1c-48ef-a24d-c16df6bcfdad
• NDC: 55513-132
• Product Type: Human Prescription Drug
• Proprietary Name: Kanjinti
• Generic Name: Trastuzumab-anns
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-06-11
• Marketing Category: BLA / BLA
• Application Number: BLA761073
• Labeler Name: Amgen Inc
• Substance Name: TRASTUZUMAB
• Active Ingredient Strength: 420 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 55513-132-01

1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01) > 20 mL in 1 VIAL, MULTI-DOSE

• Marketing Start Date: 2019-06-11
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-132-01 [55513013201]

Kanjinti INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2019-06-11

Drug Details

Active Ingredients

Ingredient	Strength
TRASTUZUMAB	420 mg/20mL

OpenFDA Data

• SPL SET ID: 9a94f5b2-b84e-4987-8ea1-c4346db5a5fa
• Manufacturer:
  • Amgen Inc
• UNII:
  • P188ANX8CK
• RxNorm Concept Unique ID - RxCUI:
  • 2174809
  • 2174804

Pharmacological Class

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

NDC Crossover Matching brand name "Kanjinti" or generic name "Trastuzumab-anns"

NDC	Brand Name	Generic Name
55513-132	Kanjinti	trastuzumab-anns
55513-141	Kanjinti	trastuzumab-anns