avsola

Generic: infliximab-axxq

Labeler: amgen, inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name avsola
Generic Name infliximab-axxq
Labeler amgen, inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

infliximab 100 mg/10mL

Manufacturer
Amgen, Inc

Identifiers & Regulatory

Product NDC 55513-670
Product ID 55513-670_6b1480b9-1db9-4bbc-91e3-e967574f2055
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA761086
Listing Expiration 2026-12-31
Marketing Start 2019-12-12

Pharmacologic Class

Established (EPC)
tumor necrosis factor blocker [epc]
Mechanism of Action
tumor necrosis factor receptor blocking activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55513670
Hyphenated Format 55513-670

Supplemental Identifiers

RxCUI
2266525 2266530
UNII
B72HH48FLU
NUI
N0000175610 N0000175451

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name avsola (source: ndc)
Generic Name infliximab-axxq (source: ndc)
Application Number BLA761086 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-01) / 10 mL in 1 VIAL, SINGLE-DOSE
  • 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-21) / 10 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (2)

55513-670-01 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-01) / 10 mL in 1 VIAL, SINGLE-DOSE 55513-670-21 1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-21) / 10 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

infliximab (100 mg/10mL)

Linked Drug Pages (1)

AVSOLA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "6b1480b9-1db9-4bbc-91e3-e967574f2055", "openfda": {"nui": ["N0000175610", "N0000175451"], "unii": ["B72HH48FLU"], "rxcui": ["2266525", "2266530"], "spl_set_id": ["de34bcb7-b524-45c8-9181-61c6f48d540e"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Amgen, Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-01)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-670-01", "marketing_start_date": "20191212"}, {"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 CARTON (55513-670-21)  / 10 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "55513-670-21", "marketing_start_date": "20250901"}], "brand_name": "AVSOLA", "product_id": "55513-670_6b1480b9-1db9-4bbc-91e3-e967574f2055", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "55513-670", "generic_name": "infliximab-axxq", "labeler_name": "Amgen, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "AVSOLA", "active_ingredients": [{"name": "INFLIXIMAB", "strength": "100 mg/10mL"}], "application_number": "BLA761086", "marketing_category": "BLA", "marketing_start_date": "20191212", "listing_expiration_date": "20261231"}