FDA.reportPublic FDA data

Osenvelt

Product NDC
72606-038
11-digit product format
726060038
Labeler code
72606
Product ID
72606-038_ccc3be04-f9b8-46d8-a1a9-0aacdb418c3b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
denosumab-bmwo
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
CELLTRION USA, Inc.
Application
BLA761404
Marketing category
BLA
Marketing start
2025-07-02
Substance
DENOSUMAB
Active strength
120 mg/1.7mL
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
Osenvelt
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB120 mg/1.7mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui2717866, 2717873

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
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
db5ebcdb-b6ae-21cd-4dc5-76cd84b5578bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72606-038-01Osenvelt1 in 1 CARTONINJECTION17
72606-038-01Osenvelt1.7 mL in 1 VIAL, SINGLE-USEINJECTION1.77

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72606-038-01ML - Milliliter72606-03839ed21d4-c790-46ef-9443-f076e260e41012025-07-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717866denosumab-bmwo 120 MG in 1.7 ML InjectionPSNc5a5d750-80be-49cd-b4a6-c8a8159560597
2717873Osenvelt 120 MG in 1.7 ML InjectionPSNc5a5d750-80be-49cd-b4a6-c8a8159560597
27178731.7 ML denosumab-bmwo 70 MG/ML Injection [Osenvelt]SBDc5a5d750-80be-49cd-b4a6-c8a8159560597
27178661.7 ML denosumab-bmwo 70 MG/ML InjectionSCDc5a5d750-80be-49cd-b4a6-c8a8159560597
27178731.7 ML Osenvelt 70 MG/ML InjectionSYc5a5d750-80be-49cd-b4a6-c8a8159560597
2717866denosumab-bmwo 120 MG per 1.7 ML InjectionSYc5a5d750-80be-49cd-b4a6-c8a8159560597
2717873Osenvelt 120 MG per 1.7 ML InjectionSYc5a5d750-80be-49cd-b4a6-c8a8159560597

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72606-038-01726060038011 VIAL, SINGLE-USE in 1 CARTON (72606-038-01) / 1.7 mL in 1 VIAL, SINGLE-USE2025-07-02NoNoHistorical