FDA.reportPublic FDA data

IV Solution Stabilizer

Product NDC
0310-4715
11-digit product format
003104715
Labeler code
0310
Product ID
0310-4715_a9e94288-ebc3-49b7-b07b-9f2cd4439631
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
IV Solution Stabilizer
Dosage form
SOLUTION
Route
INTRAVENOUS
Labeler
AstraZeneca Pharmaceuticals LP
Application
BLA761104
Marketing category
BLA
Marketing start
2018-10-24
Marketing end
0000-00-00
Substance
POLYSORBATE 80
Active strength
7 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0310-4715DDiscontinued by firm2026-07-31
excluded packagepackage0310-47150310-4715-11DDiscontinued by firm2026-07-31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0310-4715-11ML - Milliliter0310-4715b3e50471-c01f-49eb-9edf-24b2f24d4a5412018-11-06

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761104Lumoxitimoxetumomab pasudotox-tdfk351(a)Disc2026-06-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0310-4715-11003104715111 VIAL in 1 CARTON (0310-4715-11) > 1 mL in 1 VIAL1 vial2018-10-240000-00-00NoNoCurrent