FDA.reportPublic FDA data

BOMYNTRA

Product NDC
65219-670
11-digit product format
652190670
Labeler code
65219
Product ID
65219-670_fd3a3b73-bf8e-4538-9eee-b3d652251260
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Denosumab
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Fresenius Kabi USA, LLC
Application
BLA761398
Marketing category
BLA
Marketing start
2025-06-30
Substance
DENOSUMAB
Active strength
70 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
BOMYNTRA
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DENOSUMAB70 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4EQZ6YO2HI
Rxcui2717542, 2717549, 2717551, 2717555

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
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
65219-670-01BOMYNTRA1 in 1 CARTONINJECTION13
65219-670-01BOMYNTRA1.7 mL in 1 VIAL, SINGLE-DOSEINJECTION1.73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-670-01ML - Milliliter65219-67033699a8d-c3aa-498e-abb4-ff7c0790793812025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2717549Bomyntra 120 MG in 1.7 ML InjectionPSN49d25732-e05d-47e4-98cb-67df04796d4b3
2717555Bomyntra 120 MG in 1.7 ML Prefilled SyringePSN49d25732-e05d-47e4-98cb-67df04796d4b3
2717542denosumab-bnht 120 MG in 1.7 ML InjectionPSN49d25732-e05d-47e4-98cb-67df04796d4b3
2717551denosumab-bnht 120 MG in 1.7 ML Prefilled SyringePSN49d25732-e05d-47e4-98cb-67df04796d4b3
27175491.7 ML denosumab-bnht 70 MG/ML Injection [Bomyntra]SBD49d25732-e05d-47e4-98cb-67df04796d4b3
27175551.7 ML denosumab-bnht 70 MG/ML Prefilled Syringe [Bomyntra]SBD49d25732-e05d-47e4-98cb-67df04796d4b3
27175421.7 ML denosumab-bnht 70 MG/ML InjectionSCD49d25732-e05d-47e4-98cb-67df04796d4b3
27175511.7 ML denosumab-bnht 70 MG/ML Prefilled SyringeSCD49d25732-e05d-47e4-98cb-67df04796d4b3
2717549Bomyntra 120 MG per 1.7 ML InjectionSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717555Bomyntra 120 MG per 1.7 ML Prefilled SyringeSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717549Bomyntra 70 MG/ML per 1.7 ML InjectionSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717555Bomyntra 70 MG/ML per 1.7 ML Prefilled SyringeSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717542denosumab-bnht 120 MG per 1.7 ML InjectionSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717551denosumab-bnht 120 MG per 1.7 ML Prefilled SyringeSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717542denosumab-bnht 70 MG/ML per 1.7 ML InjectionSY49d25732-e05d-47e4-98cb-67df04796d4b3
2717551denosumab-bnht 70 MG/ML per 1.7 ML Prefilled SyringeSY49d25732-e05d-47e4-98cb-67df04796d4b3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
65219-670-01652190670011 VIAL, SINGLE-DOSE in 1 CARTON (65219-670-01) / 1.7 mL in 1 VIAL, SINGLE-DOSE2025-06-30NoNoHistorical