NDC 55513-670

AVSOLA

Infliximab-axxq

AVSOLA is a Intravenous Injection, Powder, Lyophilized, For Solution in the Human Prescription Drug category. It is labeled and distributed by Amgen Inc. The primary component is Infliximab.

• Product ID: 55513-670_05eea39f-c8af-4004-90cb-7276e7996509
• NDC: 55513-670
• Product Type: Human Prescription Drug
• Proprietary Name: AVSOLA
• Generic Name: Infliximab-axxq
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-12-12
• Marketing Category: BLA / BLA
• Application Number: BLA761086
• Labeler Name: Amgen Inc
• Substance Name: INFLIXIMAB
• Active Ingredient Strength: 100 mg/10mL
• Pharm Classes: Tumor Necrosis Factor Blocker [EPC], Tumor Necrosis Factor Receptor Blocking Activity [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 55513-670-01

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

• Marketing Start Date: 2019-12-12
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 55513-670-01 [55513067001]

AVSOLA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA761086
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2019-12-12

Drug Details

Active Ingredients

Ingredient	Strength
INFLIXIMAB	100 mg/10mL

Pharmacological Class

• Tumor Necrosis Factor Blocker [EPC]
• Tumor Necrosis Factor Receptor Blocking Activity [MoA]
• Tumor Necrosis Factor Blocker [EPC]
• Tumor Necrosis Factor Receptor Blocking Activity [MoA]