inflectra

Generic: infliximab-dyyb

Labeler: pfizer laboratories div pfizer inc
NDC Directory HUMAN PRESCRIPTION DRUG BLA Inactive Finished

Drug Facts

Product Profile

Brand Name inflectra
Generic Name infliximab-dyyb
Labeler pfizer laboratories div pfizer inc
Dosage Form INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

infliximab 100 mg/10mL

Manufacturer
Pfizer Laboratories Div Pfizer Inc

Identifiers & Regulatory

Product NDC 0069-0809
Product ID 0069-0809_421960f4-55cd-4bf8-9f00-b980b020e7a7
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category BLA
Application Number BLA125544
Listing Expiration 2026-12-31
Marketing Start 2016-11-21

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 00690809
Hyphenated Format 0069-0809

Supplemental Identifiers

RxCUI
1790541 1790546
UPC
0300690809014
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 inflectra (source: ndc)
Generic Name infliximab-dyyb (source: ndc)
Application Number BLA125544 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 100 mg/10mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01) / 10 mL in 1 VIAL, SINGLE-USE
source: ndc

Packages (1)

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

Ingredients (1)

infliximab (100 mg/10mL)

Linked Drug Pages (1)

INFLECTRA ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "421960f4-55cd-4bf8-9f00-b980b020e7a7", "openfda": {"nui": ["N0000175610", "N0000175451"], "upc": ["0300690809014"], "unii": ["B72HH48FLU"], "rxcui": ["1790541", "1790546"], "spl_set_id": ["37eaca10-d812-48bc-8b8e-b836bfa9968f"], "pharm_class_epc": ["Tumor Necrosis Factor Blocker [EPC]"], "pharm_class_moa": ["Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "manufacturer_name": ["Pfizer Laboratories Div Pfizer Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-USE in 1 CARTON (0069-0809-01)  / 10 mL in 1 VIAL, SINGLE-USE", "package_ndc": "0069-0809-01", "marketing_start_date": "20161121"}], "brand_name": "INFLECTRA", "product_id": "0069-0809_421960f4-55cd-4bf8-9f00-b980b020e7a7", "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "pharm_class": ["Tumor Necrosis Factor Blocker [EPC]", "Tumor Necrosis Factor Receptor Blocking Activity [MoA]"], "product_ndc": "0069-0809", "generic_name": "infliximab-dyyb", "labeler_name": "Pfizer Laboratories Div Pfizer Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "INFLECTRA", "active_ingredients": [{"name": "INFLIXIMAB", "strength": "100 mg/10mL"}], "application_number": "BLA125544", "marketing_category": "BLA", "marketing_start_date": "20161121", "listing_expiration_date": "20261231"}