FDA.reportPublic FDA data

Rybrevant Faspro

Product NDC
57894-515
Requested package NDC
57894-515-01
11-digit product format
578940515
Labeler code
57894
Product ID
57894-515_e037897a-b42a-413f-8f3f-c0f5ee7b5125
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
AMIVANTAMAB and HYALURONIDASE-lpuj (HUMAN RECOMBINANT)
Dosage form
INJECTION
Route
SUBCUTANEOUS
Labeler
Janssen Biotech, Inc.
Application
BLA761484
Marketing category
BLA
Marketing start
2026-02-13
Substance
AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
2400; 30000 mg/15mL; mg/15mL
Pharmacologic classes
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
Rybrevant Faspro
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AMIVANTAMAB2400 mg/15mL
HYALURONIDASE (HUMAN RECOMBINANT)30000 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
743QUY4VD8Internal UNII lookup
0JSR7Z0NB6Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2729297Internal RxNorm lookup
2729304Internal RxNorm lookup
2729306Internal RxNorm lookup
2729307Internal RxNorm lookup
2735796Internal RxNorm lookup
2735797Internal RxNorm lookup
2735803Internal RxNorm lookup
2735804Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9e58b045-e352-4f62-99bf-77fae1bebc69Available 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
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
4da1cc6f-1454-4667-9e32-0182fda070c5Product name120211209
bd11614e-4776-4a92-aaca-2bcbb5f710edProduct name120210115
0c6eff6a-9a1e-468b-b9ca-6bc864c2e8cbProduct name120200925
6d78c268-2e9d-bd45-9f2d-965fd0e582caProduct name220200323
b914e981-d6dc-4748-bd51-accd6b85b817Product name120190618
48747306-602a-42cc-957b-5b0c69158eeeProduct name120180604
4597a7a9-59c8-4eb4-b516-4f26fa3dfe4bProduct name120170804
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
57894-515-01Rybrevant Faspro1 in 1 CARTONINJECTION14
57894-515-01Rybrevant Faspro15 mL in 1 VIAL, SINGLE-DOSEINJECTION154

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-515-01ML - Milliliter57894-515fa224e04-5be0-4d95-8ebd-718571e8323c12026-03-17

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
Rybrevant FasproAMIVANTAMAB AND HYALURONIDASE-LPUJ (HUMAN RECOMBINANT)Janssen Biotech, Inc.9e58b045-e352-4f62-99bf-77fae1bebc692026-06-17Warnings, Adverse reactionsExact identifier
ndc (package): 57894-515-01
ndc (product): 57894-515
ndc11 (package): 57894051501

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761484Rybrevant Fasproamivantamab and hyaluronidase-lpuj351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2729297amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT in 10 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2729306amivantamab-lpuj 2240 MG / hyaluronidase-lpuj 28000 UNT in 14 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2735796amivantamab-lpuj 2400 MG / hyaluronidase-lpuj 30000 UNT in 15 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2735803amivantamab-lpuj 3520 MG / hyaluronidase-lpuj 44000 UNT in 22 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2729304Rybrevant Faspro 1600 MG / 20000 UNT in 10 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2729307Rybrevant Faspro 2240 MG / 28000 UNT in 14 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2735797Rybrevant Faspro 2400 MG / 30000 UNT in 15 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
2735804Rybrevant Faspro 3520 MG / 44000 UNT in 22 ML InjectionPSN9e58b045-e352-4f62-99bf-77fae1bebc694
272930410 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]SBD9e58b045-e352-4f62-99bf-77fae1bebc694
272930714 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]SBD9e58b045-e352-4f62-99bf-77fae1bebc694
273579715 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]SBD9e58b045-e352-4f62-99bf-77fae1bebc694
273580422 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML Injection [Rybrevant Faspro]SBD9e58b045-e352-4f62-99bf-77fae1bebc694
272929710 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML InjectionSCD9e58b045-e352-4f62-99bf-77fae1bebc694
272930614 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML InjectionSCD9e58b045-e352-4f62-99bf-77fae1bebc694
273579615 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML InjectionSCD9e58b045-e352-4f62-99bf-77fae1bebc694
273580322 ML amivantamab-lpuj 160 MG/ML / hyaluronidase-lpuj 2000 UNT/ML InjectionSCD9e58b045-e352-4f62-99bf-77fae1bebc694
2729297amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT per 10 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2729306amivantamab-lpuj 2240 MG / hyaluronidase-lpuj 28000 UNT per 14 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735796amivantamab-lpuj 2400 MG / hyaluronidase-lpuj 30000 UNT per 15 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735803amivantamab-lpuj 3520 MG / hyaluronidase-lpuj 44000 UNT per 22 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2729304Rybrevant Faspro (amivantamab-lpuj 1600 MG / hyaluronidase-lpuj 20000 UNT) per 10 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2729307Rybrevant Faspro (amivantamab-lpuj 2240 MG / hyaluronidase-lpuj 28000 UNT) per 14 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735797Rybrevant Faspro (amivantamab-lpuj 2400 MG / hyaluronidase-lpuj 30000 UNT) per 15 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735804Rybrevant Faspro (amivantamab-lpuj 3520 MG / hyaluronidase-lpuj 44000 UNT) per 22 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2729304Rybrevant Faspro 1600 MG / 20000 UNT per 10 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2729307Rybrevant Faspro 2240 MG / 28000 UNT per 14 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735797Rybrevant Faspro 2400 MG / 30000 UNT per 15 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694
2735804Rybrevant Faspro 3520 MG / 44000 UNT per 22 ML InjectionSY9e58b045-e352-4f62-99bf-77fae1bebc694

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
57894-515-01578940515011 VIAL, SINGLE-DOSE in 1 CARTON (57894-515-01) / 15 mL in 1 VIAL, SINGLE-DOSE2026-02-13NoNoCurrent