FDA.reportPublic FDA data

Phesgo

Product NDC
50242-260
11-digit product format
502420260
Labeler code
50242
Product ID
50242-260_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
20000; 600; 600 U/10mL; mg/10mL; mg/10mL
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
HYALURONIDASE (HUMAN RECOMBINANT)20000 U/10mL
PERTUZUMAB600 mg/10mL
TRASTUZUMAB600 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP188ANX8CK, 743QUY4VD8, K16AIQ8CTM
Rxcui2382604, 2382609, 2383305, 2383307

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
50242-260-01Phesgo10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1017
50242-260-01Phesgo1 in 1 CARTONINJECTION, SOLUTION117
50242-260-86Phesgo10 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION1017
50242-260-86Phesgo1 in 1 CARTONINJECTION, SOLUTION117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-260-01ML - Milliliter50242-26065b48726-a0bc-4826-bfe6-4f2fb8387cce12020-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-260PHESGO (PERTUZUMAB, TRASTUZUMAB, AND HYALURONIDASE-ZZXF) INJECTION, SOLUTION [GENENTECH, INC.]10Current NDC, Legacy NDC, 4 package rows20241206_27dd5e6b-72cd-458d-a015-cf4dab5800da.zip

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
50242-260-01502420260011 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-01) / 10 mL in 1 VIAL, SINGLE-DOSE2020-06-290000-00-00NoNoCurrent
50242-260-86502420260861 VIAL, SINGLE-DOSE in 1 CARTON (50242-260-86) / 10 mL in 1 VIAL, SINGLE-DOSE2021-05-030000-00-00YesNoCurrent