FDA.reportPublic FDA data

Bimzelx

Product NDC
50474-780
11-digit product format
504740780
Labeler code
50474
Product ID
50474-780_37b310bd-f6a0-9d4e-e063-6294a90a889d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
bimekizumab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
UCB, Inc.
Application
BLA761151
Marketing category
BLA
Marketing start
2023-10-17
Substance
BIMEKIZUMAB
Active strength
160 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bimzelx
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BIMEKIZUMAB160 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii09495UIM6V
Rxcui2668086, 2668093, 2668099, 2668103, 2699121, 2699122, 2699123, 2699124

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
638793e0-5f5d-4e9c-ac0f-43a545543d29Product name120250515
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50474-780-78Bimzelx1 in 1 CARTONINJECTION, SOLUTION114
50474-780-78Bimzelx1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION114
50474-780-79Bimzelx2 in 1 CARTONINJECTION, SOLUTION214
50474-780-79Bimzelx1 mL in 1 SYRINGE, GLASSINJECTION, SOLUTION114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50474-780-78ML - Milliliter50474-7805234ea85-5319-4a92-b0a8-d40b94e99eff12024-10-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50474-780BIMZELX (BIMEKIZUMAB) INJECTION, SOLUTION [UCB, INC.]12Current NDC, 4 package rows20250519_26b88358-871f-4c80-9d80-b2fb16477f81.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2668099bimekizumab-bkzx 160 MG in 1 ML Auto-InjectorPSN26b88358-871f-4c80-9d80-b2fb16477f8114
2668086bimekizumab-bkzx 160 MG in 1 ML Prefilled SyringePSN26b88358-871f-4c80-9d80-b2fb16477f8114
2699121bimekizumab-bkzx 320 MG in 2 ML Auto-InjectorPSN26b88358-871f-4c80-9d80-b2fb16477f8114
2699123bimekizumab-bkzx 320 MG in 2 ML Prefilled SyringePSN26b88358-871f-4c80-9d80-b2fb16477f8114
2668103Bimzelx 160 MG in 1 ML Auto-InjectorPSN26b88358-871f-4c80-9d80-b2fb16477f8114
2668093Bimzelx 160 MG in 1 ML Prefilled SyringePSN26b88358-871f-4c80-9d80-b2fb16477f8114
2699122Bimzelx 320 MG in 2 ML Auto-InjectorPSN26b88358-871f-4c80-9d80-b2fb16477f8114
2699124Bimzelx 320 MG in 2 ML Prefilled SyringePSN26b88358-871f-4c80-9d80-b2fb16477f8114
26681031 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]SBD26b88358-871f-4c80-9d80-b2fb16477f8114
26680931 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx]SBD26b88358-871f-4c80-9d80-b2fb16477f8114
26991222 ML bimekizumab-bkzx 160 MG/ML Auto-Injector [Bimzelx]SBD26b88358-871f-4c80-9d80-b2fb16477f8114
26991242 ML bimekizumab-bkzx 160 MG/ML Prefilled Syringe [Bimzelx]SBD26b88358-871f-4c80-9d80-b2fb16477f8114
26680991 ML bimekizumab-bkzx 160 MG/ML Auto-InjectorSCD26b88358-871f-4c80-9d80-b2fb16477f8114
26680861 ML bimekizumab-bkzx 160 MG/ML Prefilled SyringeSCD26b88358-871f-4c80-9d80-b2fb16477f8114
26991212 ML bimekizumab-bkzx 160 MG/ML Auto-InjectorSCD26b88358-871f-4c80-9d80-b2fb16477f8114
26991232 ML bimekizumab-bkzx 160 MG/ML Prefilled SyringeSCD26b88358-871f-4c80-9d80-b2fb16477f8114
26681031 ML Bimzelx 160 MG/ML Auto-InjectorSY26b88358-871f-4c80-9d80-b2fb16477f8114
2668099bimekizumab-bkzx 160 MG per 1 ML Auto-InjectorSY26b88358-871f-4c80-9d80-b2fb16477f8114
2668086bimekizumab-bkzx 160 MG per 1 ML Prefilled SyringeSY26b88358-871f-4c80-9d80-b2fb16477f8114
2699121bimekizumab-bkzx 320 MG per 2 ML Auto-InjectorSY26b88358-871f-4c80-9d80-b2fb16477f8114
2699123bimekizumab-bkzx 320 MG per 2 ML Prefilled SyringeSY26b88358-871f-4c80-9d80-b2fb16477f8114
2668103Bimzelx 160 MG per 1 ML Auto-InjectorSY26b88358-871f-4c80-9d80-b2fb16477f8114
2668093Bimzelx 160 MG per 1 ML Prefilled SyringeSY26b88358-871f-4c80-9d80-b2fb16477f8114
2699122Bimzelx 320 MG per 2 ML Auto-InjectorSY26b88358-871f-4c80-9d80-b2fb16477f8114
2699124Bimzelx 320 MG per 2 ML Prefilled SyringeSY26b88358-871f-4c80-9d80-b2fb16477f8114

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
50474-780-78504740780781 SYRINGE, GLASS in 1 CARTON (50474-780-78) / 1 mL in 1 SYRINGE, GLASS2024-10-01NoNoHistorical
50474-780-79504740780792 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS2023-10-17NoNoHistorical