FDA.reportPublic FDA data

Kanjinti

Product NDC
55513-132
11-digit product format
555130132
Labeler code
55513
Product ID
55513-132_94338615-f26e-4373-93ce-106894c98a87
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trastuzumab-anns
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
BLA761073
Marketing category
BLA
Marketing start
2019-06-11
Substance
TRASTUZUMAB
Active strength
420 mg/20mL
Pharmacologic classes
HER2/Neu/cerbB2 Antagonists [MoA], 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
Kanjinti
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB420 mg/20mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P188ANX8CKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2174804Internal RxNorm lookup
2174809Internal RxNorm lookup
2257297Internal RxNorm lookup
2257300Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9a94f5b2-b84e-4987-8ea1-c4346db5a5faAvailable on FDA.report

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
55513-132-01Kanjinti1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122
55513-132-01Kanjinti20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,2022
55513-132-21Kanjinti20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,2022
55513-132-21Kanjinti1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,122

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-132-01EA - Each55513-132ff67e395-eebc-4daa-84d2-8a0f0d7efb1212019-08-06
55513-132-21EA - Each55513-1329a1dbcce-660d-426d-9ba2-b108908b5f9712026-02-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-132KANJINTI (TRASTUZUMAB-ANNS) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION KANJINTI (TRASTUZUMAB-ANNS) KIT [AMGEN INC]19Current NDC, Legacy NDC, 4 package rows20250205_9a94f5b2-b84e-4987-8ea1-c4346db5a5fa.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
KanjintiTRASTUZUMAB-ANNSAmgen, Inc9a94f5b2-b84e-4987-8ea1-c4346db5a5fa2026-06-23Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761073
ndc (product): 55513-132

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761073Kanjintitrastuzumab-anns351(k) BiosimilarRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2257300KANJINTI 150 MG InjectionPSN9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174809KANJINTI 420 MG in 20 mL Injectable SolutionPSN9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2257297trastuzumab-anns 150 MG InjectionPSN9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174804trastuzumab-anns 420 MG in 20 mL Injectable SolutionPSN9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2257300trastuzumab-anns 150 MG Injection [Kanjinti]SBD9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174809trastuzumab-anns 21 MG/ML Injectable Solution [Kanjinti]SBD9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2257297trastuzumab-anns 150 MG InjectionSCD9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174804trastuzumab-anns 21 MG/ML Injectable SolutionSCD9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2257300Kanjinti 150 MG InjectionSY9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174809Kanjinti 21 MG/ML Injectable SolutionSY9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174809Kanjinti 420 MG per 20 ML Injectable SolutionSY9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22
2174804trastuzumab-anns 420 MG per 20 ML Injectable SolutionSY9a94f5b2-b84e-4987-8ea1-c4346db5a5fa22

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-132-01555130132011 VIAL, MULTI-DOSE in 1 CARTON (55513-132-01) / 20 mL in 1 VIAL, MULTI-DOSE2019-06-110000-00-00NoNoCurrent
55513-132-21555130132211 VIAL, MULTI-DOSE in 1 CARTON (55513-132-21) / 20 mL in 1 VIAL, MULTI-DOSE2025-07-01NoNoCurrent