FDA.reportPublic FDA data

ENOBY

Product NDC
0143-9165
11-digit product format
001439165
Labeler code
0143
Product ID
0143-9165_ddf6eb2a-4e1f-4cb4-992a-c93cbb5c0cfb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Denosumab-qbde
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Hikma Pharmaceuticals USA Inc.
Application
BLA761439
Marketing category
BLA
Marketing start
2026-01-08
Substance
DENOSUMAB
Active strength
60 mg/mL
Pharmacologic classes
RANK Ligand Blocking Activity [MoA], RANK Ligand Inhibitor [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4EQZ6YO2HIInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2725566Internal RxNorm lookup
2725573Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
815d3ba4-27a1-4a06-925a-a87f35442bdbAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
31f7a69c-73ae-42bf-97ee-e31040596ed6Product name120180423
b45e2e3f-1908-4144-8fa5-6f481dea7435Product name120170721
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0143-9165-01ENOBY1 mL in 1 SYRINGEINJECTION15
0143-9165-01ENOBY1 in 1 CARTONINJECTION15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0143-9165-01ML - Milliliter0143-9165bf993c23-2f63-4524-b931-1945e0156baf12026-02-05

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ENOBYDENOSUMAB-QBDEHikma Pharmaceuticals USA Inc.815d3ba4-27a1-4a06-925a-a87f35442bdb2026-01-16Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761439
ndc (product): 0143-9165
XTRENBODENOSUMAB-QBDEHikma Pharmaceuticals USA Inc.a48a3a33-6b0e-4cf4-8786-8f662d6ee77b2025-09-02Warnings, Adverse reactionsExact identifier
application number: BLA761439

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761439Enobydenosumab-qbde351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725566denosumab-qbde 60 MG in 1 ML Prefilled SyringePSN815d3ba4-27a1-4a06-925a-a87f35442bdb5
2725573Enoby 60 MG in 1 ML Prefilled SyringePSN815d3ba4-27a1-4a06-925a-a87f35442bdb5
27255731 ML denosumab-qbde 60 MG/ML Prefilled Syringe [Enoby]SBD815d3ba4-27a1-4a06-925a-a87f35442bdb5
27255661 ML denosumab-qbde 60 MG/ML Prefilled SyringeSCD815d3ba4-27a1-4a06-925a-a87f35442bdb5
27255731 ML Enoby 60 MG/ML Prefilled SyringeSY815d3ba4-27a1-4a06-925a-a87f35442bdb5
2725566denosumab-qbde 60 MG per 1 ML Prefilled SyringeSY815d3ba4-27a1-4a06-925a-a87f35442bdb5
2725573Enoby 60 MG per 1 ML Prefilled SyringeSY815d3ba4-27a1-4a06-925a-a87f35442bdb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0143-9165-01001439165011 SYRINGE in 1 CARTON (0143-9165-01) / 1 mL in 1 SYRINGE1 syringe2026-01-08NoNoCurrent