Phesgo

Product NDC
50242-245
11-digit product format
502420245
Labeler code
50242
Product ID
50242-245_9d068707-f189-4f0f-a74e-17bbe1f10476
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
pertuzumab, trastuzumab, and hyaluronidase-zzxf
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
Genentech, Inc.
Application
BLA761170
Marketing category
BLA
Marketing start
2020-06-29
Substance
HYALURONIDASE (HUMAN RECOMBINANT); PERTUZUMAB; TRASTUZUMAB
Active strength
30000; 1200; 600 U/15mL; mg/15mL; mg/15mL
Pharmacologic classes
Endoglycosidase [EPC], Glycoside Hydrolases [CS], HER2/Neu/cerbB2 Antagonists [MoA], HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Phesgo
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PERTUZUMAB30000 U/15mL
TRASTUZUMAB1200 mg/15mL
HYALURONIDASE (HUMAN RECOMBINANT)600 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P188ANX8CKInternal UNII lookup
K16AIQ8CTMInternal UNII lookup
743QUY4VD8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2382604Internal RxNorm lookup
2382609Internal RxNorm lookup
2383305Internal RxNorm lookup
2383307Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
27dd5e6b-72cd-458d-a015-cf4dab5800daAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8cProduct name120190610
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
222f5094-f738-47bd-890e-8847eb1d8ce4Product name120150930
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-245-01Phesgo15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1517
50242-245-01Phesgo1 in 1 CARTONINJECTION, SOLUTION117
50242-245-86Phesgo1 in 1 CARTONINJECTION, SOLUTION117
50242-245-86Phesgo15 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1517

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-245-01ML - Milliliter50242-24542ae8a2b-5a0d-4238-b682-0f462d38746912020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-245PHESGO (PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF) INJECTION, SOLUTION [GENENTECH, INC.]10Current NDC, Legacy NDC, 4 package rows20241206_27dd5e6b-72cd-458d-a015-cf4dab5800da.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PhesgoPERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXFGenentech, Inc.27dd5e6b-72cd-458d-a015-cf4dab5800da2026-05-21Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761170
ndc (product): 50242-245

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761170Phesgopertuzumab, trastuzumab, and hyaluronidase-zzxf351(a)Rx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2382604pertuzumab-trastuzumab-hyaluronidase-zzxf 1,200 MG / 600 MG / 30,000 UNT in 15 mL InjectionPSN27dd5e6b-72cd-458d-a015-cf4dab5800da17
2383305pertuzumab-trastuzumab-hyaluronidase-zzxf 600 MG / 600 MG / 20,000 UNT in 10 ML InjectionPSN27dd5e6b-72cd-458d-a015-cf4dab5800da17
2382609PHESGO 1,200 MG / 600 MG / 30,000 UNT in 15 ML InjectionPSN27dd5e6b-72cd-458d-a015-cf4dab5800da17
2383307Phesgo 600 MG / 600 MG / 20,000 UNT in 10 mL InjectionPSN27dd5e6b-72cd-458d-a015-cf4dab5800da17
238330710 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 60 MG/ML / trastuzumab-zzxf 60 MG/ML Injection [Phesgo]SBD27dd5e6b-72cd-458d-a015-cf4dab5800da17
238260915 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 80 MG/ML / trastuzumab-zzxf 40 MG/ML Injection [Phesgo]SBD27dd5e6b-72cd-458d-a015-cf4dab5800da17
238330510 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 60 MG/ML / trastuzumab-zzxf 60 MG/ML InjectionSCD27dd5e6b-72cd-458d-a015-cf4dab5800da17
238260415 ML hyaluronidase-zzxf 2000 UNT/ML / pertuzumab-zzxf 80 MG/ML / trastuzumab-zzxf 40 MG/ML InjectionSCD27dd5e6b-72cd-458d-a015-cf4dab5800da17
2382604pertuzumab-trastuzumab-hyaluronidase-zzxf 1,200 MG / 600 MG / 30,000 UNT per 15 ML InjectionSY27dd5e6b-72cd-458d-a015-cf4dab5800da17
2383305pertuzumab-trastuzumab-hyaluronidase-zzxf 600 MG / 600 MG / 20,000 UNT per 10 ML InjectionSY27dd5e6b-72cd-458d-a015-cf4dab5800da17
2382609Phesgo 1,200 MG / 600 MG / 30,000 UNT per 15 ML InjectionSY27dd5e6b-72cd-458d-a015-cf4dab5800da17
2383307Phesgo 600 MG / 600 MG / 20,000 UNT per 10 ML InjectionSY27dd5e6b-72cd-458d-a015-cf4dab5800da17

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-245-01502420245011 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-01) / 15 mL in 1 VIAL, SINGLE-DOSE2020-06-290000-00-00NoNoCurrent
50242-245-86502420245861 VIAL, SINGLE-DOSE in 1 CARTON (50242-245-86) / 15 mL in 1 VIAL, SINGLE-DOSE2021-05-030000-00-00YesNoCurrent