FDA.reportPublic FDA data

IMULDOSA

Product NDC
51407-931
11-digit product format
514070931
Labeler code
51407
Product ID
51407-931_49688baa-0c74-cd48-e063-6294a90a81c2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-srlf
Dosage form
INJECTION
Route
INTRAVENOUS
Labeler
Golden State Medical Supply, Inc.
Application
BLA761364
Marketing category
BLA
Marketing start
2024-10-10
Substance
USTEKINUMAB-SRLF
Active strength
130 mg/26mL
Pharmacologic classes
Interleukin-12 Antagonist [EPC], Interleukin-12 Antagonists [MoA], Interleukin-23 Antagonist [EPC], Interleukin-23 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct51407-931DDiscontinued by firm2026-08-17
excluded packagepackage51407-93151407-931-11DDiscontinued by firm2026-08-17

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9101c6a6-2dd0-4586-9db6-ccb20dc679c9Product name220171206
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51407-931-11IMULDOSA26 mL in 1 VIAL, SINGLE-USEINJECTION263
51407-931-11IMULDOSA1 in 1 CARTONINJECTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51407-931-11ML - Milliliter51407-9310e10a664-1443-4fa2-a528-80049169a78212025-08-11

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
IMULDOSAUSTEKINUMAB-SRLFAccord BioPharma Inc.2539a6cf-0fe5-1565-e063-6294a90a36182026-06-17Warnings, Adverse reactionsExact identifier
application number: BLA761364

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761364Imuldosaustekinumab-srlf351(k) InterchangeableRx2026-08-01

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
51407-931-11514070931111 VIAL, SINGLE-USE in 1 CARTON (51407-931-11) / 26 mL in 1 VIAL, SINGLE-USE2025-06-18NoNoHistorical