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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB60 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui2725928, 2725935

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

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