FDA.reportPublic FDA data

BENLYSTA

Product NDC
49401-088
11-digit product format
494010088
Labeler code
49401
Product ID
49401-088_379d7f58-8f17-44b3-8336-6fe8ef015aed
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
belimumab
Dosage form
SOLUTION
Route
SUBCUTANEOUS
Labeler
GlaxoSmithKline LLC
Application
BLA761043
Marketing category
BLA
Marketing start
2017-07-20
Substance
BELIMUMAB
Active strength
200 mg/mL
Pharmacologic classes
B Lymphocyte Stimulator-directed Antibody Interactions [MoA], B Lymphocyte Stimulator-specific Inhibitor [EPC], Decreased B Lymphocyte Activation [PE]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BELIMUMAB200 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii73B0K5S26A
Rxcui1656395, 1656398, 1656400, 1656402, 1939296, 1939299, 1939346, 1939348

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
2cc1dd89-5388-4737-a41d-2073e055fa56Product name220190716
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49401-088-01BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-02BENLYSTA1 in 1 CARTONSOLUTION137
49401-088-35BENLYSTA4 in 1 CARTONSOLUTION437
49401-088-42BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-47BENLYSTA4 in 1 CARTONSOLUTION437
49401-088-50BENLYSTA1 in 1 CARTONSOLUTION137
49401-088-61BENLYSTA1 mL in 1 SYRINGESOLUTION137
49401-088-61BENLYSTA1 in 1 CARTONSOLUTION137

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49401-088-01ML - Milliliter49401-088bcf92992-9bad-464c-9d35-ac1a5039ded212017-08-11
49401-088-35ML - Milliliter49401-088032d8042-004e-4b1c-ba71-6da76b6a296812017-08-11
49401-088-42ML - Milliliter49401-088d29db4cf-ac8e-4023-83e0-f45c6c8669f512017-08-11
49401-088-47ML - Milliliter49401-0881a653d99-ed2e-487f-9d87-c06f594b421712017-08-11
49401-088-61ML - Milliliter49401-08881ce2c39-0bcf-4952-b030-94e59fee110812022-05-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BELIMUMABACTIVE INGREDIENT73B0K5S26ABENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
BELIMUMABACTIVE MOIETY73B0K5S26ABENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULRBENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12
SUCROSEINACTIVE INGREDIENTC151H8M554BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [HUMAN GENOME SCIENCES, INC.]12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49401-088BENLYSTA (BELIMUMAB) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION BENLYSTA (BELIMUMAB) SOLUTION [GLAXOSMITHKLINE LLC]34Current NDC, Legacy NDC, 8 package rows20241220_2fa3c528-1777-4628-8a55-a69dae2381a3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1656395belimumab 120 MG InjectionPSN2fa3c528-1777-4628-8a55-a69dae2381a337
1939296belimumab 200 MG in 1 ML Auto-InjectorPSN2fa3c528-1777-4628-8a55-a69dae2381a337
1939346belimumab 200 MG in 1 ML Prefilled SyringePSN2fa3c528-1777-4628-8a55-a69dae2381a337
1656400belimumab 400 MG InjectionPSN2fa3c528-1777-4628-8a55-a69dae2381a337
1656398Benlysta 120 MG InjectionPSN2fa3c528-1777-4628-8a55-a69dae2381a337
1939299Benlysta 200 MG in 1 ML Auto-InjectorPSN2fa3c528-1777-4628-8a55-a69dae2381a337
1939348Benlysta 200 MG in 1 ML Prefilled SyringePSN2fa3c528-1777-4628-8a55-a69dae2381a337
1656402Benlysta 400 MG InjectionPSN2fa3c528-1777-4628-8a55-a69dae2381a337
19392991 ML belimumab 200 MG/ML Auto-Injector [Benlysta]SBD2fa3c528-1777-4628-8a55-a69dae2381a337
19393481 ML belimumab 200 MG/ML Prefilled Syringe [Benlysta]SBD2fa3c528-1777-4628-8a55-a69dae2381a337
1656398belimumab 120 MG Injection [Benlysta]SBD2fa3c528-1777-4628-8a55-a69dae2381a337
1656402belimumab 400 MG Injection [Benlysta]SBD2fa3c528-1777-4628-8a55-a69dae2381a337
19392961 ML belimumab 200 MG/ML Auto-InjectorSCD2fa3c528-1777-4628-8a55-a69dae2381a337
19393461 ML belimumab 200 MG/ML Prefilled SyringeSCD2fa3c528-1777-4628-8a55-a69dae2381a337
1656395belimumab 120 MG InjectionSCD2fa3c528-1777-4628-8a55-a69dae2381a337
1656400belimumab 400 MG InjectionSCD2fa3c528-1777-4628-8a55-a69dae2381a337
19392991 ML Benlysta 200 MG/ML Auto-InjectorSY2fa3c528-1777-4628-8a55-a69dae2381a337
19393481 ML Benlysta 200 MG/ML Prefilled SyringeSY2fa3c528-1777-4628-8a55-a69dae2381a337
1939296belimumab 200 MG per 1 ML Auto-InjectorSY2fa3c528-1777-4628-8a55-a69dae2381a337
1939346belimumab 200 MG per 1 ML Prefilled SyringeSY2fa3c528-1777-4628-8a55-a69dae2381a337
1656398Benlysta 120 MG InjectionSY2fa3c528-1777-4628-8a55-a69dae2381a337
1939299Benlysta 200 MG per 1 ML Auto-InjectorSY2fa3c528-1777-4628-8a55-a69dae2381a337
1939348Benlysta 200 MG per 1 ML Prefilled SyringeSY2fa3c528-1777-4628-8a55-a69dae2381a337
1656402Benlysta 400 MG InjectionSY2fa3c528-1777-4628-8a55-a69dae2381a337

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49401-088-01494010088011 mL in 1 SYRINGE1 mlHistorical
49401-088-02494010088021 SYRINGE in 1 CARTON (49401-088-02) / 1 mL in 1 SYRINGE (49401-088-01) 1 syringe2017-07-200000-00-00NoNoCurrent
49401-088-35494010088354 SYRINGE in 1 CARTON (49401-088-35) / 1 mL in 1 SYRINGE (49401-088-01) 4 syringe2017-07-200000-00-00NoNoCurrent
49401-088-42494010088421 mL in 1 SYRINGE1 mlHistorical
49401-088-47494010088474 SYRINGE in 1 CARTON (49401-088-47) / 1 mL in 1 SYRINGE (49401-088-42) 4 syringe2017-07-200000-00-00NoNoCurrent
49401-088-50494010088501 SYRINGE in 1 CARTON (49401-088-50) / 1 mL in 1 SYRINGE (49401-088-42) 1 syringe2017-07-200000-00-00NoNoCurrent
49401-088-61494010088611 SYRINGE in 1 CARTON (49401-088-61) / 1 mL in 1 SYRINGE1 syringe2020-06-020000-00-00YesNoCurrent