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#

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 productproduct51407-931DDiscontinued by firm2026-07-31
excluded packagepackage51407-93151407-931-11DDiscontinued by firm2026-07-31

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761364Imuldosaustekinumab-srlf351(k) InterchangeableRx2026-06-01

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