herzuma

Generic: trastuzumab

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

Drug Facts

Product Profile

Brand Name herzuma
Generic Name trastuzumab
Labeler cephalon, inc.
Dosage Form KIT
Manufacturer
Cephalon, Inc.

Identifiers & Regulatory

Product NDC 63459-305
Product ID 63459-305_49f6182a-5e0f-45ea-8a0f-b774ef28a98f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761091
Listing Expiration 2026-12-31
Marketing Start 2020-03-16

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 63459305
Hyphenated Format 63459-305

Supplemental Identifiers

RxCUI
2107053 2107058 2169359 2169362
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 herzuma (source: ndc)
Generic Name trastuzumab (source: ndc)
Application Number BLA761091 (source: ndc)
Routes
intravenous
source: label

Resolved Composition

Strengths
  • 150 mg
  • 420 mg
  • 20 ml
  • 1.1 %
source: label
Packaging
  • 1 KIT in 1 CARTON (63459-305-47) * 50 mL in 1 VIAL, MULTI-DOSE (63459-307-41) * 20 mL in 1 VIAL (63459-221-20)
source: ndc

Packages (1)

63459-305-47 1 KIT in 1 CARTON (63459-305-47) * 50 mL in 1 VIAL, MULTI-DOSE (63459-307-41) * 20 mL in 1 VIAL (63459-221-20)

Ingredients (0)

No ingredient records.

Linked Drug Pages (1)

HERZUMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"spl_id": "49f6182a-5e0f-45ea-8a0f-b774ef28a98f", "openfda": {"nui": ["N0000175661", "N0000020008"], "unii": ["P188ANX8CK"], "rxcui": ["2107053", "2107058", "2169359", "2169362"], "spl_set_id": ["ae71c003-883a-4cd8-ad50-e8cc9a54e971"], "pharm_class_epc": ["HER2/neu Receptor Antagonist [EPC]"], "pharm_class_moa": ["HER2/Neu/cerbB2 Antagonists [MoA]"], "manufacturer_name": ["Cephalon, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 KIT in 1 CARTON (63459-305-47)  *  50 mL in 1 VIAL, MULTI-DOSE (63459-307-41)  *  20 mL in 1 VIAL (63459-221-20)", "package_ndc": "63459-305-47", "marketing_start_date": "20200316"}], "brand_name": "HERZUMA", "product_id": "63459-305_49f6182a-5e0f-45ea-8a0f-b774ef28a98f", "dosage_form": "KIT", "product_ndc": "63459-305", "generic_name": "TRASTUZUMAB", "labeler_name": "Cephalon, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HERZUMA", "application_number": "BLA761091", "marketing_category": "BLA", "marketing_start_date": "20200316", "listing_expiration_date": "20261231"}