kanjinti

Generic: trastuzumab-anns

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name kanjinti
Generic Name trastuzumab-anns
Labeler amgen, inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

trastuzumab 420 mg/20mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-132
Product ID 55513-132_0921bf2c-8d88-4b27-bcf2-7e776577ffe1
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761073
Listing Expiration 2026-12-31
Marketing Start 2019-06-11

Pharmacologic Class

Established (EPC)
her2/neu receptor antagonist [epc]
Mechanism of Action
her2/neu/cerbb2 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513132
Hyphenated Format 55513-132

Supplemental Identifiers

RxCUI
2174804 2174809 2257297 2257300
UNII
P188ANX8CK
NUI
N0000175661 N0000020008

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name kanjinti (source: ndc)
Generic Name trastuzumab-anns (source: ndc)
Application Number BLA761073 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 420 mg/20mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01) / 20 mL in 1 VIAL, MULTI-DOSE
  • 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-21) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (2)

55513-132-01 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01) / 20 mL in 1 VIAL, MULTI-DOSE 55513-132-21 1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-21) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

trastuzumab (420 mg/20mL)

Linked Drug Pages (1)

Kanjinti ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "0921bf2c-8d88-4b27-bcf2-7e776577ffe1", "openfda": {"nui": ["N0000175661", "N0000020008"], "unii": ["P188ANX8CK"], "rxcui": ["2174804", "2174809", "2257297", "2257300"], "spl_set_id": ["9a94f5b2-b84e-4987-8ea1-c4346db5a5fa"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55513-132-01", "marketing_start_date": "20190611"}, {"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 CARTON (55513-132-21)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "55513-132-21", "marketing_start_date": "20250701"}], "brand_name": "Kanjinti", "product_id": "55513-132_0921bf2c-8d88-4b27-bcf2-7e776577ffe1", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "55513-132", "generic_name": "trastuzumab-anns", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Kanjinti", "active_ingredients": [{"name": "TRASTUZUMAB", "strength": "420 mg/20mL"}], "application_number": "BLA761073", "marketing_category": "BLA", "marketing_start_date": "20190611", "listing_expiration_date": "20261231"}