FDA.reportPublic FDA data

Herceptin

Product NDC
50242-132
11-digit product format
502420132
Labeler code
50242
Product ID
50242-132_5e75840c-4462-440a-9e17-caa80dd4127b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Trastuzumab
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Genentech, Inc.
Application
BLA103792
Marketing category
BLA
Marketing start
2017-02-10
Substance
TRASTUZUMAB
Active strength
150 mg/7.4mL
Pharmacologic classes
HER2/Neu/cerbB2 Antagonists [MoA], HER2/neu Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB150 mg/7.4mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP188ANX8CK

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
9397f6d4-17a1-42b4-beda-fa2c0ea40c8cProduct name120190610
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50242-132-01Herceptin1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,126
50242-132-01Herceptin15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1526
50242-132-10Herceptin10 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,1026
50242-132-10Herceptin15 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1526

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50242-132-01EA - Each50242-13257463a6f-9e34-44d8-8fc7-5785545ee60a12017-06-15
50242-132-10EA - Each50242-1327208e0ba-85f6-4923-91ba-0c850b30459912019-06-19

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
TRASTUZUMABACTIVE INGREDIENTP188ANX8CKHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
TRASTUZUMABACTIVE MOIETYP188ANX8CKHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBHHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
HISTIDINEINACTIVE INGREDIENT4QD397987EHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
HISTIDINE MONOHYDROCHLORIDEINACTIVE INGREDIENT1D5Q932XM6HERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
POLYSORBATE 20INACTIVE INGREDIENT7T1F30V5YHHERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7
TREHALOSE DIHYDRATEINACTIVE INGREDIENT7YIN7J07X4HERCEPTIN (TRASTUZUMAB) KIT [GENENTECH, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50242-132HERCEPTIN (TRASTUZUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [GENENTECH, INC.]26Current NDC, Legacy NDC, 4 package rows20241121_492dbdb2-077e-4064-bff3-372d6af0a7a2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50242-132-01502420132011 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-01) / 15 mL in 1 VIAL, SINGLE-DOSE2017-02-100000-00-00NoNoCurrent
50242-132-105024201321010 VIAL, SINGLE-DOSE in 1 CARTON (50242-132-10) > 15 mL in 1 VIAL, SINGLE-DOSE2019-06-030000-00-00NoNoCurrent