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 Identifiers#

Field, Values table
FieldValues
UniiP188ANX8CK
Rxcui2174804, 2174809, 2257297, 2257300

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

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-DOSE2025-07-01NoNoHistorical