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

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

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