FDA.reportPublic FDA data

Trazimera

Product NDC
0069-0308
11-digit product format
000690308
Labeler code
0069
Product ID
0069-0308_6bb3d11b-6f9e-408c-a957-b7bacaf9e175
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
trastuzumab-qyyp
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Pfizer Laboratories Div Pfizer Inc
Application
BLA761081
Marketing category
BLA
Marketing start
2021-03-10
Substance
TRASTUZUMAB
Active strength
150 mg/7.15mL
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
Trazimera
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
TRASTUZUMAB150 mg/7.15mL

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
2280732Internal RxNorm lookup
2280737Internal RxNorm lookup
2472791Internal RxNorm lookup
2472794Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b9c5e894-27d2-4245-a653-df986fed3c56Available 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
0069-0308-01Trazimera1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,19
0069-0308-01Trazimera7.15 mL in 1 VIALINJECTION, POWDER, LYOPHILIZED,7.159

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0069-0308-01EA - Each0069-030871841720-a34d-4e68-a8ad-a7e6ebfc495412021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0069-0308TRAZIMERA (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

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
TrazimeraTRASTUZUMAB-QYYPPfizer Laboratories Div Pfizer Incb9c5e894-27d2-4245-a653-df986fed3c562026-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761081
ndc (product): 0069-0308

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761081Trazimeratrastuzumab-qyyp351(k) BiosimilarRx2026-07-01

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
0069-0308-01000690308011 VIAL in 1 CARTON (0069-0308-01) / 7.15 mL in 1 VIAL1 vial2021-03-100000-00-00NoNoCurrent