FDA.reportPublic FDA data

BOMYNTRA

Product NDC
65219-672
11-digit product format
652190672
Labeler code
65219
Product ID
65219-672_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 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 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2717542Internal RxNorm lookup
2717549Internal RxNorm lookup
2717551Internal RxNorm lookup
2717555Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
49d25732-e05d-47e4-98cb-67df04796d4bAvailable on FDA.report

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
65219-672-01BOMYNTRA1 in 1 CARTONINJECTION13
65219-672-01BOMYNTRA1.7 mL in 1 SYRINGE, PLASTICINJECTION1.73

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
65219-672-01ML - Milliliter65219-6729871c021-873d-4600-bba4-98f2ab16aafd12025-08-11

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
CONEXXENCEDENOSUMABFresenius Kabi USA, LLC39a0a789-778f-4695-b3a9-61643e6396cd2025-12-15Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761398
BOMYNTRADENOSUMABFresenius Kabi USA, LLC49d25732-e05d-47e4-98cb-67df04796d4b2025-03-31Warnings, Adverse reactionsExact identifier
application number: BLA761398
ndc (product): 65219-672

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761398Conexxencedenosumab-bnht351(k) InterchangeableRx2026-07-01

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
65219-672-01652190672011 SYRINGE, PLASTIC in 1 CARTON (65219-672-01) / 1.7 mL in 1 SYRINGE, PLASTIC2025-06-30NoNoCurrent