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#

Ingredient, Strength table
Ingredient	Strength
DURVALUMAB	120 mg/2.4mL

Field, Values table
Field	Values
Unii	28X28X9OKV
Rxcui	1919507, 1919512, 1919515, 1919516

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d55ff371-b52d-49fb-95d1-a5869b7178cb	Product name	1	20170711
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0310-4500-12	IMFINZI	1 in 1 CARTON	INJECTION, SOLUTION	1		32
0310-4500-12	IMFINZI	2.4 mL in 1 VIAL	INJECTION, SOLUTION	2.4		32

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0310-4500-12	ML - Milliliter	0310-4500	05dc92ff-aaa2-4361-a857-da9efd307f7c	1	2017-06-15

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0310-4500	IMFINZI (DURVALUMAB) INJECTION, SOLUTION [ASTRAZENECA PHARMACEUTICALS LP]	31	Current NDC, Legacy NDC, 2 package rows	20250410_8baba4ea-2855-42fa-9bd9-5a7548d4cec3.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
28X28X9OKV	DURVALUMAB	1428935-60-7	DURVALUMAB

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1919507	durvalumab 120 in 2.4 ML Injection	PSN	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919515	durvalumab 500 MG in 10 ML Injection	PSN	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919512	IMFINZI 120 MG in 2.4 ML Injection	PSN	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919516	IMFINZI 500 MG in 10 ML Injection	PSN	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919516	10 ML durvalumab 50 MG/ML Injection [Imfinzi]	SBD	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919512	2.4 ML durvalumab 50 MG/ML Injection [Imfinzi]	SBD	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919515	10 ML durvalumab 50 MG/ML Injection	SCD	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919507	2.4 ML durvalumab 50 MG/ML Injection	SCD	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919516	10 ML Imfinzi 50 MG/ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919512	2.4 ML Imfinzi 50 MG/ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919507	durvalumab 120 per 2.4 ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919515	durvalumab 500 MG per 10 ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919512	IMFINZI 120 MG per 2.4 ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32
1919516	IMFINZI 500 MG per 10 ML Injection	SY	8baba4ea-2855-42fa-9bd9-5a7548d4cec3	32

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0310-4500-12	00310450012	1 VIAL in 1 CARTON (0310-4500-12) / 2.4 mL in 1 VIAL	1 vial	2017-05-01	0000-00-00	No	No	Current