FDA.reportPublic FDA data

Exdensur

Product NDC
0173-0927
11-digit product format
001730927
Labeler code
0173
Product ID
0173-0927_a34e2ed2-aeb5-4d39-a44c-6996a763e4de
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
depemokimab
Dosage form
INJECTION, SOLUTION
Route
SUBCUTANEOUS
Labeler
GlaxoSmithKline LLC
Application
BLA761458
Marketing category
BLA
Marketing start
2025-12-16
Substance
DEPEMOKIMAB
Active strength
100 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEPEMOKIMAB100 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
D16EQP0KKHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2729271Internal RxNorm lookup
2729278Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
30332b20-2ac0-42ad-a775-d3ca7f5fe29fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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
0173-0927-31Exdensur1 in 1 CARTONINJECTION, SOLUTION13
0173-0927-31Exdensur1 mL in 1 SYRINGEINJECTION, SOLUTION13
0173-0927-42Exdensur1 in 1 CARTONINJECTION, SOLUTION13
0173-0927-42Exdensur1 mL in 1 SYRINGEINJECTION, SOLUTION13
0173-0927-61Exdensur1 mL in 1 SYRINGEINJECTION, SOLUTION13
0173-0927-61Exdensur1 in 1 CARTONINJECTION, SOLUTION13

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0173-0927-42ML - Milliliter0173-09275b3a816f-5cdd-4209-9f29-e75c61c07e9012026-01-08

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
ExdensurDEPEMOKIMABGlaxoSmithKline LLC30332b20-2ac0-42ad-a775-d3ca7f5fe29f2026-06-10Warnings, Adverse reactionsExact identifier
application number: BLA761458
ndc (product): 0173-0927

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761458Exdensurdepemokimab-ulaa351(a)Disc2026-08-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729271depemokimab-ulaa 100 MG in 1 ML Prefilled SyringePSN30332b20-2ac0-42ad-a775-d3ca7f5fe29f3
2729278EXDENSUR 100 MG in 1 ML Prefilled SyringePSN30332b20-2ac0-42ad-a775-d3ca7f5fe29f3
27292781 ML depemokimab-ulaa 100 MG/ML Prefilled Syringe [Exdensur]SBD30332b20-2ac0-42ad-a775-d3ca7f5fe29f3
27292711 ML depemokimab-ulaa 100 MG/ML Prefilled SyringeSCD30332b20-2ac0-42ad-a775-d3ca7f5fe29f3
2729271depemokimab-ulaa 100 MG per 1 ML Prefilled SyringeSY30332b20-2ac0-42ad-a775-d3ca7f5fe29f3
2729278Exdensur 100 MG per 1 ML Prefilled SyringeSY30332b20-2ac0-42ad-a775-d3ca7f5fe29f3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0173-0927-31001730927311 in 1 CARTONHistorical
0173-0927-42001730927421 SYRINGE in 1 CARTON (0173-0927-42) / 1 mL in 1 SYRINGE1 syringe2025-12-16NoNoCurrent
0173-0927-61001730927611 SYRINGE in 1 CARTON (0173-0927-61) / 1 mL in 1 SYRINGE1 syringe2026-03-30NoNoCurrent