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 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

trastuzumab 150 mg/7.15mL

Manufacturer
Cephalon, Inc.

Identifiers & Regulatory

Product NDC 63459-303
Product ID 63459-303_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 63459303
Hyphenated Format 63459-303

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: ndc

Resolved Composition

Strengths
  • 150 mg/7.15mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43) / 20 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

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

Ingredients (1)

trastuzumab (150 mg/7.15mL)

Linked Drug Pages (1)

HERZUMA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "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 VIAL, SINGLE-DOSE in 1 CARTON (63459-303-43)  / 20 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "63459-303-43", "marketing_start_date": "20200316"}], "brand_name": "HERZUMA", "product_id": "63459-303_49f6182a-5e0f-45ea-8a0f-b774ef28a98f", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["HER2/Neu/cerbB2 Antagonists [MoA]", "HER2/neu Receptor Antagonist [EPC]"], "product_ndc": "63459-303", "generic_name": "TRASTUZUMAB", "labeler_name": "Cephalon, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "HERZUMA", "active_ingredients": [{"name": "TRASTUZUMAB", "strength": "150 mg/7.15mL"}], "application_number": "BLA761091", "marketing_category": "BLA", "marketing_start_date": "20200316", "listing_expiration_date": "20261231"}