FDA.reportPublic FDA data

BOSAYA

Product NDC
83257-029
11-digit product format
832570029
Labeler code
83257
Product ID
83257-029_9e7bd621-7366-63fc-2aa6-06dcd1f8e605
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Denosumab-kyqq
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Biocon Biologics Inc.
Application
BLA761436
Marketing category
BLA
Marketing start
2026-01-05
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
BOSAYA
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
2725928Internal RxNorm lookup
2725935Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1e5e8c88-3c65-3076-e44b-02d92c2d343dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
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
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83257-029-41BOSAYA1 mL in 1 SYRINGEINJECTION12
83257-029-41BOSAYA1 in 1 CARTONINJECTION12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
83257-029-41ML - Milliliter83257-02998fc2c4e-d93e-4aba-a999-98352a4ae53212026-03-17

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
AUKELSODENOSUMAB-KYQQBiocon Biologics Inc.547cb095-f7f5-f933-75ce-5e6abf2ad5bc2026-03-27Warnings, Adverse reactionsExact identifier
application number: BLA761436
BOSAYADENOSUMAB-KYQQBiocon Biologics Inc.1e5e8c88-3c65-3076-e44b-02d92c2d343d2026-03-27Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761436
ndc (product): 83257-029

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761436Bosayadenosumab-kyqq351(k) InterchangeableRx2026-07-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2725935Bosaya 60 MG in 1 ML Prefilled SyringePSN1e5e8c88-3c65-3076-e44b-02d92c2d343d2
2725928denosumab-kyqq 60 MG in 1 ML Prefilled SyringePSN1e5e8c88-3c65-3076-e44b-02d92c2d343d2
27259351 ML denosumab-kyqq 60 MG/ML Prefilled Syringe [Bosaya]SBD1e5e8c88-3c65-3076-e44b-02d92c2d343d2
27259281 ML denosumab-kyqq 60 MG/ML Prefilled SyringeSCD1e5e8c88-3c65-3076-e44b-02d92c2d343d2
27259351 ML Bosaya 60 MG/ML Prefilled SyringeSY1e5e8c88-3c65-3076-e44b-02d92c2d343d2
2725935Bosaya 60 MG per 1 ML Prefilled SyringeSY1e5e8c88-3c65-3076-e44b-02d92c2d343d2
2725928denosumab-kyqq 60 MG per 1 ML Prefilled SyringeSY1e5e8c88-3c65-3076-e44b-02d92c2d343d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83257-029-41832570029411 SYRINGE in 1 CARTON (83257-029-41) / 1 mL in 1 SYRINGE1 syringe2026-01-05NoNoCurrent