lifitegrast

Generic: lifitegrast

Labeler: aurobindo pharma limited
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name lifitegrast
Generic Name lifitegrast
Labeler aurobindo pharma limited
Dosage Form FOR SOLUTION
Routes
OPHTHALMIC
Active Ingredients

lifitegrast 50 mg/mL

Manufacturer
Aurobindo Pharma Limited

Identifiers & Regulatory

Product NDC 59651-450
Product ID 59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215063
Listing Expiration 2026-12-31
Marketing Start 2023-11-07

Pharmacologic Class

Established (EPC)
lymphocyte function-associated antigen-1 antagonist [epc]
Mechanism of Action
lymphocyte function-associated antigen-1 antagonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 59651450
Hyphenated Format 59651-450

Supplemental Identifiers

RxCUI
1801835
UNII
038E5L962W
NUI
N0000192701 N0000192700

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 lifitegrast (source: ndc)
Generic Name lifitegrast (source: ndc)
Application Number ANDA215063 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE
source: ndc

Packages (1)

59651-450-60 60 POUCH in 1 CARTON (59651-450-60) / 5 AMPULE in 1 POUCH (59651-450-05) / .2 mL in 1 AMPULE

Ingredients (1)

lifitegrast (50 mg/mL)

Linked Drug Pages (1)

Lifitegrast ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "1d4b4b61-79da-4b6f-bb19-056d111bf400", "openfda": {"nui": ["N0000192701", "N0000192700"], "unii": ["038E5L962W"], "rxcui": ["1801835"], "spl_set_id": ["1d4b4b61-79da-4b6f-bb19-056d111bf400"], "pharm_class_epc": ["Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]"], "pharm_class_moa": ["Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"], "manufacturer_name": ["Aurobindo Pharma Limited"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "60 POUCH in 1 CARTON (59651-450-60)  / 5 AMPULE in 1 POUCH (59651-450-05)  / .2 mL in 1 AMPULE", "package_ndc": "59651-450-60", "marketing_start_date": "20231107"}], "brand_name": "Lifitegrast", "product_id": "59651-450_1d4b4b61-79da-4b6f-bb19-056d111bf400", "dosage_form": "FOR SOLUTION", "pharm_class": ["Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]", "Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"], "product_ndc": "59651-450", "generic_name": "Lifitegrast", "labeler_name": "Aurobindo Pharma Limited", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Lifitegrast", "active_ingredients": [{"name": "LIFITEGRAST", "strength": "50 mg/mL"}], "application_number": "ANDA215063", "marketing_category": "ANDA", "marketing_start_date": "20231107", "listing_expiration_date": "20261231"}