FDA.reportPublic FDA data

AVSOLA

Product NDC
55513-670
11-digit product format
555130670
Labeler code
55513
Product ID
55513-670_6b1480b9-1db9-4bbc-91e3-e967574f2055
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
infliximab-axxq
Dosage form
INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Route
INTRAVENOUS
Labeler
Amgen, Inc
Application
BLA761086
Marketing category
BLA
Marketing start
2019-12-12
Substance
INFLIXIMAB
Active strength
100 mg/10mL
Pharmacologic classes
Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB100 mg/10mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
B72HH48FLUInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
de34bcb7-b524-45c8-9181-61c6f48d540eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fd7a994a-5706-4fb6-ad0f-bf950de5c161Product name120250721
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6e0fa83e-7840-4808-ae8f-3478d418847bProduct name120230703
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55513-670-01AVSOLA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118
55513-670-01AVSOLA10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1018
55513-670-21AVSOLA10 mL in 1 VIAL, SINGLE-DOSEINJECTION, POWDER, LYOPHILIZED,1018
55513-670-21AVSOLA1 in 1 CARTONINJECTION, POWDER, LYOPHILIZED,118

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
55513-670-01EA - Each55513-670a3bd66e5-8d7c-4c9e-a6b0-c42e6410094312020-06-05
55513-670-21EA - Each55513-670662c4c83-211a-4138-a167-a1c788b4fe8312026-05-22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55513-670AVSOLA (INFLIXIMAB-AXXQ) INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION [AMGEN INC]13Current NDC, Legacy NDC, 4 package rows20241114_de34bcb7-b524-45c8-9181-61c6f48d540e.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
AVSOLAINFLIXIMAB-AXXQAmgen, Incde34bcb7-b524-45c8-9181-61c6f48d540e2026-07-22Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA761086
ndc (product): 55513-670

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
761086Avsolainfliximab-axxq351(k) BiosimilarRx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2266530AVSOLA 100 MG InjectionPSNde34bcb7-b524-45c8-9181-61c6f48d540e18
2266525inFLIXimab-axxq 100 MG InjectionPSNde34bcb7-b524-45c8-9181-61c6f48d540e18
2266530infliximab-axxq 100 MG Injection [Avsola]SBDde34bcb7-b524-45c8-9181-61c6f48d540e18
2266525infliximab-axxq 100 MG InjectionSCDde34bcb7-b524-45c8-9181-61c6f48d540e18
2266530Avsola 100 MG InjectionSYde34bcb7-b524-45c8-9181-61c6f48d540e18

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
55513-670-01555130670011 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-01) / 10 mL in 1 VIAL, SINGLE-DOSE2019-12-120000-00-00NoNoCurrent
55513-670-21555130670211 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-21) / 10 mL in 1 VIAL, SINGLE-DOSE2025-09-01NoNoCurrent