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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
09495UIM6VInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2668086Internal RxNorm lookup
2668093Internal RxNorm lookup
2668099Internal RxNorm lookup
2668103Internal RxNorm lookup
2699121Internal RxNorm lookup
2699122Internal RxNorm lookup
2699123Internal RxNorm lookup
2699124Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
26b88358-871f-4c80-9d80-b2fb16477f81Available on FDA.report

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

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
BimzelxBIMEKIZUMABUCB, Inc.26b88358-871f-4c80-9d80-b2fb16477f812025-06-16Warnings, Adverse reactionsExact identifier
application number: BLA761151
ndc (product): 50474-780

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761151Bimzelxbimekizumab-bkzx351(a)Rx2026-06-01

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, GLASS2024-10-01NoNoCurrent
50474-780-79504740780792 SYRINGE, GLASS in 1 CARTON (50474-780-79) / 1 mL in 1 SYRINGE, GLASS2023-10-17NoNoCurrent