FDA.reportPublic FDA data

Darzalex Faspro

Product NDC
57894-503
Requested package NDC
57894-503-01
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 UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Z63YK6E0EInternal UNII lookup
743QUY4VD8Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2375136Internal RxNorm lookup
2375141Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4bb241af-4299-4373-8762-2d6709515db0Available on FDA.report

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

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Darzalex FasproDARATUMUMAB AND HYALURONIDASE-FIHJ (HUMAN RECOMBINANT)Janssen Biotech, Inc.4bb241af-4299-4373-8762-2d6709515db02026-02-11Warnings, Adverse reactionsExact identifier
application number: BLA761145
ndc (package): 57894-503-01
ndc (product): 57894-503
ndc11 (package): 57894050301

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761145Darzalex Fasprodaratumumab and hyaluronidase-fihj351(a)Rx2026-07-01

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