FDA.reportPublic FDA data

Rybrevant Faspro

Product NDC
57894-514
11-digit product format
578940514
Labeler code
57894
Product ID
57894-514_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
BLA761433
Marketing category
BLA
Marketing start
2025-12-19
Substance
AMIVANTAMAB; HYALURONIDASE (HUMAN RECOMBINANT)
Active strength
2240; 28000 mg/14mL; mg/14mL
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
AMIVANTAMAB2240 mg/14mL
HYALURONIDASE (HUMAN RECOMBINANT)28000 mg/14mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii743QUY4VD8, 0JSR7Z0NB6
Rxcui2729297, 2729304, 2729306, 2729307, 2735796, 2735797, 2735803, 2735804

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
57894-514-01Rybrevant Faspro1 in 1 CARTONINJECTION14
57894-514-01Rybrevant Faspro14 mL in 1 VIAL, SINGLE-DOSEINJECTION144

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57894-514-01ML - Milliliter57894-51431168bd8-e8a5-4f75-a090-70e98cabd25112026-01-08

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
57894-514-01578940514011 VIAL, SINGLE-DOSE in 1 CARTON (57894-514-01) / 14 mL in 1 VIAL, SINGLE-DOSE2025-12-19NoNoCurrent