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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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

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

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761458Exdensurdepemokimab-ulaa351(a)Rx2026-06-01

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