FDA.reportPublic FDA data

IMFINZI

Product NDC
0310-4500
11-digit product format
003104500
Labeler code
0310
Product ID
0310-4500_686baf25-364f-4124-858f-151f1dae3756
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Durvalumab
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
BLA761069
Marketing category
BLA
Marketing start
2017-05-01
Substance
DURVALUMAB
Active strength
120 mg/2.4mL
Pharmacologic classes
Antibodies, Monoclonal [CS], Programmed Death Ligand-1 Antagonists [MoA], Programmed Death Ligand-1 Blocker [EPC], Programmed Death Ligand-1-directed Antibody Interactions [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DURVALUMAB120 mg/2.4mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
28X28X9OKVInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1919507Internal RxNorm lookup
1919512Internal RxNorm lookup
1919515Internal RxNorm lookup
1919516Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8baba4ea-2855-42fa-9bd9-5a7548d4cec3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d55ff371-b52d-49fb-95d1-a5869b7178cbProduct name120170711
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0310-4500-12IMFINZI1 in 1 CARTONINJECTION, SOLUTION132
0310-4500-12IMFINZI2.4 mL in 1 VIALINJECTION, SOLUTION2.432

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-4500-12ML - Milliliter0310-450005dc92ff-aaa2-4361-a857-da9efd307f7c12017-06-15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0310-4500IMFINZI (DURVALUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]31Current NDC, Legacy NDC, 2 package rows20250410_8baba4ea-2855-42fa-9bd9-5a7548d4cec3.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
IMFINZIDURVALUMABAstraZeneca Pharmaceuticals LP8baba4ea-2855-42fa-9bd9-5a7548d4cec32026-05-28Warnings, Adverse reactionsExact identifier
application number: BLA761069
ndc (product): 0310-4500

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761069Imfinzidurvalumab351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1919507durvalumab 120 in 2.4 ML InjectionPSN8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919515durvalumab 500 MG in 10 ML InjectionPSN8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919512IMFINZI 120 MG in 2.4 ML InjectionPSN8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919516IMFINZI 500 MG in 10 ML InjectionPSN8baba4ea-2855-42fa-9bd9-5a7548d4cec332
191951610 ML durvalumab 50 MG/ML Injection [Imfinzi]SBD8baba4ea-2855-42fa-9bd9-5a7548d4cec332
19195122.4 ML durvalumab 50 MG/ML Injection [Imfinzi]SBD8baba4ea-2855-42fa-9bd9-5a7548d4cec332
191951510 ML durvalumab 50 MG/ML InjectionSCD8baba4ea-2855-42fa-9bd9-5a7548d4cec332
19195072.4 ML durvalumab 50 MG/ML InjectionSCD8baba4ea-2855-42fa-9bd9-5a7548d4cec332
191951610 ML Imfinzi 50 MG/ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332
19195122.4 ML Imfinzi 50 MG/ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919507durvalumab 120 per 2.4 ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919515durvalumab 500 MG per 10 ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919512IMFINZI 120 MG per 2.4 ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332
1919516IMFINZI 500 MG per 10 ML InjectionSY8baba4ea-2855-42fa-9bd9-5a7548d4cec332

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-4500-12003104500121 VIAL in 1 CARTON (0310-4500-12) / 2.4 mL in 1 VIAL1 vial2017-05-010000-00-00NoNoCurrent