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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
P188ANX8CKTRASTUZUMAB180288-69-1TRASTUZUMAB

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0069-0308-01000690308011 VIAL in 1 CARTON (0069-0308-01) / 7.15 mL in 1 VIAL1 vial2021-03-10NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
TrazimeraPfizer Laboratories Div Pfizer Inc | Pfizer Ireland Pharmaceuticals Unlimited Company | Pfizer Manufacturing Belgium NV | Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC2026-04-10HUMAN PRESCRIPTION DRUG LABEL9