NDC 0069-0809

INFLECTRA

Infliximab-dyyb

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

• Product ID: 0069-0809_11db24ec-e95d-4127-a1e8-fb3aa917317d
• NDC: 0069-0809
• Product Type: Human Prescription Drug
• Proprietary Name: INFLECTRA
• Generic Name: Infliximab-dyyb
• Dosage Form: Injection, Powder, Lyophilized, For Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2016-11-21
• Marketing Category: BLA / BLA
• Application Number: BLA125544
• Labeler Name: Pfizer Laboratories Div Pfizer 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 0069-0809-01

1 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01) > 10 mL in 1 VIAL, SINGLE-USE

• Marketing Start Date: 2016-11-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0069-0809-01 [00069080901]

INFLECTRA INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

• Marketing Category: BLA
• Application Number: BLA125544
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-11-21

Drug Details

Active Ingredients

Ingredient	Strength
INFLIXIMAB	100 mg/10mL

Pharmacological Class

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