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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
INFLIXIMAB100 mg/10mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiB72HH48FLU
Rxcui2266525, 2266530

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

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-DOSE2025-09-01NoNoHistorical