FDA.reportPublic FDA data

Darzalex IV

Product NDC
57894-505
11-digit product format
578940505
Labeler code
57894
Product ID
57894-505_7a931e23-16ed-4112-a593-6c1a696cd4aa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Daratumumab
Dosage form
INJECTION, SOLUTION, CONCENTRATE
Route
INTRAVENOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761036
Marketing category
BLA
Marketing start
2021-10-15
Substance
DARATUMUMAB
Active strength
100 mg/5mL
Pharmacologic classes
Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Darzalex IV
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARATUMUMAB100 mg/5mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Z63YK6E0E
Rxcui1721951, 1721956, 1726439, 1726440

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
1c235fd4-7747-45ff-88d2-1b9fd044d19bProduct name120151120
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
57894-505-05Darzalex IV5 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE543
57894-505-05Darzalex IV1 in 1 BOXINJECTION, SOLUTION, CONCENTRATE143
57894-505-20Darzalex IV1 in 1 BOXINJECTION, SOLUTION, CONCENTRATE143
57894-505-20Darzalex IV20 mL in 1 VIAL, SINGLE-DOSEINJECTION, SOLUTION, CONCENTRATE2043

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-505-05ML - Milliliter57894-50562014834-63a9-4331-a0ff-4000e85df16212023-10-16
57894-505-20ML - Milliliter57894-50572913753-d8d2-4689-8ab8-e0ef1f63320312023-10-16

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DaratumumabACTIVE INGREDIENT4Z63YK6E0EDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
DaratumumabACTIVE MOIETY4Z63YK6E0EDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
mannitolINACTIVE INGREDIENT3OWL53L36ADARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
polysorbate 20INACTIVE INGREDIENT7T1F30V5YHDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
sodium acetateINACTIVE INGREDIENT4550K0SC9BDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
sodium chlorideINACTIVE INGREDIENT451W47IQ8XDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2
waterINACTIVE INGREDIENT059QF0KO0RDARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-505DARZALEX (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE DARZALEX IV (DARATUMUMAB) INJECTION, SOLUTION, CONCENTRATE [JANSSEN BIOTECH, INC.]40Current NDC, Legacy NDC, 4 package rows20250417_a4d0efe9-5e54-467e-9eb4-56fa7d53b60b.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721951daratumumab 100 MG in 5 ML InjectionPSNa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1726439daratumumab 400 MG in 20 ML InjectionPSNa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1721956DARZALEX 100 MG in 5 ML InjectionPSNa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1726440Darzalex 400 MG in 20 ML InjectionPSNa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
172644020 ML daratumumab 20 MG/ML Injection [Darzalex]SBDa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
17219565 ML daratumumab 20 MG/ML Injection [Darzalex]SBDa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
172643920 ML daratumumab 20 MG/ML InjectionSCDa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
17219515 ML daratumumab 20 MG/ML InjectionSCDa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
172644020 ML Darzalex 20 MG/ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
17219565 ML Darzalex 20 MG/ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1721951daratumumab 100 MG per 5 ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1726439daratumumab 400 MG per 20 ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1721956Darzalex 100 MG per 5 ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43
1726440Darzalex 400 MG per 20 ML InjectionSYa4d0efe9-5e54-467e-9eb4-56fa7d53b60b43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-505-05578940505051 VIAL, SINGLE-DOSE in 1 BOX (57894-505-05) / 5 mL in 1 VIAL, SINGLE-DOSE2021-10-150000-00-00NoNoCurrent
57894-505-20578940505201 VIAL, SINGLE-DOSE in 1 BOX (57894-505-20) / 20 mL in 1 VIAL, SINGLE-DOSE2021-10-150000-00-00NoNoCurrent