FDA.reportPublic FDA data

Darzalex Faspro

Product NDC
57894-503
11-digit product format
578940503
Labeler code
57894
Product ID
57894-503_8cd9a8a9-e03e-4557-8b3b-c9d280024acf
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
daratumumab and hyaluronidase-fihj (human recombinant)
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761145
Marketing category
BLA
Marketing start
2020-05-01
Substance
DARATUMUMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
1800; 30000 mg/15mL; U/15mL
Pharmacologic classes
Antibodies, Monoclonal [CS], CD38-directed Antibody Interactions [MoA], CD38-directed Cytolytic Antibody [EPC], Endoglycosidase [EPC], Glycoside Hydrolases [CS]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DARATUMUMAB1800 mg/15mL
HYALURONIDASE (HUMAN RECOMBINANT)30000 U/15mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4Z63YK6E0E, 743QUY4VD8
Rxcui2375136, 2375141

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fba5a780-b52d-4964-b662-1526b044aec4Product name120260127
64196b0b-840e-435b-8afa-0b0e9d9cea99Product name120251024
4b151d8d-9b47-43df-bccb-6abc1c4e7194Product name120250331
d745a796-f789-46a3-afa3-79dead22a863Product name120250331
00bb4496-246c-4f2c-910a-2b2783035958Product name120231025
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
1c235fd4-7747-45ff-88d2-1b9fd044d19bProduct name120151120
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57894-503-01Darzalex Faspro15 mL in 1 VIAL, SINGLE-DOSEINJECTION1531
57894-503-01Darzalex Faspro1 in 1 BOXINJECTION131

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-503-01ML - Milliliter57894-503fa4972f1-30d0-4aad-b2c3-7e604549157c12020-06-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57894-503DARZALEX FASPRO (DARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)) INJECTION [JANSSEN BIOTECH, INC.]22Current NDC, Legacy NDC, 2 package rows20240809_4bb241af-4299-4373-8762-2d6709515db0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2375136daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT in 15 mL InjectionPSN4bb241af-4299-4373-8762-2d6709515db031
2375141DARZALEX Faspro 1800 MG / 30,000 UNT in 15 mL InjectionPSN4bb241af-4299-4373-8762-2d6709515db031
237514115 ML daratumumab-fihj 120 MG/ML / hyaluronidase-fihj 2000 UNT/ML Injection [Darzalex Faspro]SBD4bb241af-4299-4373-8762-2d6709515db031
237513615 ML daratumumab-fihj 120 MG/ML / hyaluronidase-fihj 2000 UNT/ML InjectionSCD4bb241af-4299-4373-8762-2d6709515db031
2375136daratumumab-fihj 1800 MG / hyaluronidase-fihj 30,000 UNT per 15 mL InjectionSY4bb241af-4299-4373-8762-2d6709515db031
2375141DARZALEX Faspro (daratumumab-hyaluronidase-fihj 1800 MG /30,000 UNT) per 15 ML InjectionSY4bb241af-4299-4373-8762-2d6709515db031
2375141DARZALEX Faspro 1800 MG / 30,000 UNT per 15 mL InjectionSY4bb241af-4299-4373-8762-2d6709515db031

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57894-503-01578940503011 VIAL, SINGLE-DOSE in 1 BOX (57894-503-01) / 15 mL in 1 VIAL, SINGLE-DOSE2020-05-010000-00-00NoNoCurrent