FDA.reportPublic FDA data

IMULDOSA

Product NDC
69448-017
11-digit product format
694480017
Labeler code
69448
Product ID
69448-017_450dafe8-f537-6303-e063-6394a90aa784
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
ustekinumab-srlf
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Accord BioPharma Inc.
Application
BLA761364
Marketing category
BLA
Marketing start
2024-10-14
Substance
USTEKINUMAB-SRLF
Active strength
45 mg/.5mL
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
USTEKINUMAB-SRLF45 mg/.5mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
FU77B4U5Z0Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 6 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2717067Internal RxNorm lookup
2717074Internal RxNorm lookup
2717078Internal RxNorm lookup
2717083Internal RxNorm lookup
2717085Internal RxNorm lookup
2717086Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2539a6cf-0fe5-1565-e063-6294a90a3618Available on FDA.report

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
69448-017-63IMULDOSA1 in 1 BLISTER PACKINJECTION19
69448-017-63IMULDOSA1 in 1 CARTONINJECTION19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69448-017-63ML - Milliliter69448-0179a8cd216-8bcc-4be9-95c0-1e9fc57ad19412024-12-10

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
ndc (product): 69448-017

Purple Book Biologic Products#

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717074IMULDOSA 130 MG in 26 ML InjectionPSN2539a6cf-0fe5-1565-e063-6294a90a36189
2717083IMULDOSA 45 MG in 0.5 ML Prefilled SyringePSN2539a6cf-0fe5-1565-e063-6294a90a36189
2717086IMULDOSA 90 MG in 1 ML Prefilled SyringePSN2539a6cf-0fe5-1565-e063-6294a90a36189
2717067ustekinumab-srlf 130 MG in 26 ML InjectionPSN2539a6cf-0fe5-1565-e063-6294a90a36189
2717078ustekinumab-srlf 45 MG in 0.5 ML Prefilled SyringePSN2539a6cf-0fe5-1565-e063-6294a90a36189
2717085ustekinumab-srlf 90 MG in 1 ML Prefilled SyringePSN2539a6cf-0fe5-1565-e063-6294a90a36189
27170830.5 ML ustekinumab-srlf 90 MG/ML Prefilled Syringe [Imuldosa]SBD2539a6cf-0fe5-1565-e063-6294a90a36189
27170861 ML ustekinumab-srlf 90 MG/ML Prefilled Syringe [Imuldosa]SBD2539a6cf-0fe5-1565-e063-6294a90a36189
271707426 ML ustekinumab-srlf 5 MG/ML Injection [Imuldosa]SBD2539a6cf-0fe5-1565-e063-6294a90a36189
27170780.5 ML ustekinumab-srlf 90 MG/ML Prefilled SyringeSCD2539a6cf-0fe5-1565-e063-6294a90a36189
27170851 ML ustekinumab-srlf 90 MG/ML Prefilled SyringeSCD2539a6cf-0fe5-1565-e063-6294a90a36189
271706726 ML ustekinumab-srlf 5 MG/ML InjectionSCD2539a6cf-0fe5-1565-e063-6294a90a36189
2717074Imuldosa 130 MG per 26 ML InjectionSY2539a6cf-0fe5-1565-e063-6294a90a36189
2717083Imuldosa 45 MG per 0.5 ML Prefilled SyringeSY2539a6cf-0fe5-1565-e063-6294a90a36189
2717086Imuldosa 90 MG per 1 ML Prefilled SyringeSY2539a6cf-0fe5-1565-e063-6294a90a36189
2717067ustekinumab-srlf 130 MG per 26 ML InjectionSY2539a6cf-0fe5-1565-e063-6294a90a36189
2717078ustekinumab-srlf 45 MG per 0.5 ML Prefilled SyringeSY2539a6cf-0fe5-1565-e063-6294a90a36189
2717085ustekinumab-srlf 90 MG per 1 ML Prefilled SyringeSY2539a6cf-0fe5-1565-e063-6294a90a36189

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69448-017-63694480017631 BLISTER PACK in 1 CARTON (69448-017-63) / 1 SYRINGE in 1 BLISTER PACK / .5 mL in 1 SYRINGE1 blister pack2024-10-14NoNoCurrent