Trazimera

Product NDC
0069-0305
11-digit product format
000690305
Labeler code
0069
Product ID
0069-0305_6bb3d11b-6f9e-408c-a957-b7bacaf9e175
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trastuzumab-qyyp
Dosage form
KIT
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761081
Marketing category
BLA
Marketing start
2020-02-24
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP188ANX8CK
Rxcui2280732, 2280737, 2472791, 2472794

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
0069-0305-01Trazimera1 in 1 KITKIT19
0069-0306-01Trazimera20 mL in 1 VIAL, MULTI-DOSEINJECTION, POWDER, LYOPHILIZED,20 mL420 mg in 20mL9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0305-01EA - Each0069-0305e7ebc4d7-8f37-4953-9ef6-d1c86968394c12020-03-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0305TRAZIMERA (TRASTUZUMAB-QYYP) KIT TRAZIMERA (TRASTUZUMAB-QYYP) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [PFIZER LABORATORIES DIV PFIZER INC]7Current NDC, Legacy NDC, 2 package rows20241222_b9c5e894-27d2-4245-a653-df986fed3c56.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2472791trastuzumab-qyyp 150 MG InjectionPSNb9c5e894-27d2-4245-a653-df986fed3c569
2280732trastuzumab-qyyp 420 MG in 20 ML Injectable SolutionPSNb9c5e894-27d2-4245-a653-df986fed3c569
2472794Trazimera 150 MG InjectionPSNb9c5e894-27d2-4245-a653-df986fed3c569
2280737Trazimera 420 MG in 20 mL Injectable SolutionPSNb9c5e894-27d2-4245-a653-df986fed3c569
2472794trastuzumab-qyyp 150 MG Injection [Trazimera]SBDb9c5e894-27d2-4245-a653-df986fed3c569
2280737trastuzumab-qyyp 21 MG/ML Injectable Solution [Trazimera]SBDb9c5e894-27d2-4245-a653-df986fed3c569
2472791trastuzumab-qyyp 150 MG InjectionSCDb9c5e894-27d2-4245-a653-df986fed3c569
2280732trastuzumab-qyyp 21 MG/ML Injectable SolutionSCDb9c5e894-27d2-4245-a653-df986fed3c569
2280732trastuzumab-qyyp 420 MG per 20 ML Injectable SolutionSYb9c5e894-27d2-4245-a653-df986fed3c569
2472794Trazimera 150 MG InjectionSYb9c5e894-27d2-4245-a653-df986fed3c569
2280737Trazimera 21 MG/ML Injectable SolutionSYb9c5e894-27d2-4245-a653-df986fed3c569
2280737Trazimera 420 MG per 20 ML Injectable SolutionSYb9c5e894-27d2-4245-a653-df986fed3c569

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0069-0305-01000690305011 KIT in 1 KIT (0069-0305-01) * 20 mL in 1 VIAL, MULTI-DOSE (0069-0306-01) * 20 mL in 1 VIAL (0069-0307-01) 1 kit2020-02-240000-00-00NoNoCurrent
0069-0306-010006903060120 mL in 1 VIAL, MULTI-DOSE20 mlHistorical