xiidra

Generic: lifitegrast

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name xiidra
Generic Name lifitegrast
Labeler novartis pharmaceuticals corporation
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

lifitegrast 50 mg/mL

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0911
Product ID 0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA208073
Listing Expiration 2026-12-31
Marketing Start 2016-07-11

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 00780911
Hyphenated Format 0078-0911

Supplemental Identifiers

RxCUI
1801835 1801840
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 xiidra (source: ndc)
Generic Name lifitegrast (source: ndc)
Application Number NDA208073 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE
  • 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE
source: ndc

Packages (2)

0078-0911-12 12 POUCH in 1 CARTON (0078-0911-12) / 5 AMPULE in 1 POUCH (0078-0911-05) / .2 mL in 1 AMPULE 0078-0911-94 4 POUCH in 1 CARTON (0078-0911-94) / 5 AMPULE in 1 POUCH (0078-0911-95) / .2 mL in 1 AMPULE

Ingredients (1)

lifitegrast (50 mg/mL)

Linked Drug Pages (1)

Xiidra ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "3cabbaea-c2bf-971c-e063-6394a90a4931", "openfda": {"nui": ["N0000192701", "N0000192700"], "unii": ["038E5L962W"], "rxcui": ["1801835", "1801840"], "spl_set_id": ["8589d376-ac10-4ddb-9c53-2e0c8d5675c4"], "pharm_class_epc": ["Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]"], "pharm_class_moa": ["Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "12 POUCH in 1 CARTON (0078-0911-12)  / 5 AMPULE in 1 POUCH (0078-0911-05)  / .2 mL in 1 AMPULE", "package_ndc": "0078-0911-12", "marketing_end_date": "20270601", "marketing_start_date": "20200604"}, {"sample": true, "description": "4 POUCH in 1 CARTON (0078-0911-94)  / 5 AMPULE in 1 POUCH (0078-0911-95)  / .2 mL in 1 AMPULE", "package_ndc": "0078-0911-94", "marketing_end_date": "20270201", "marketing_start_date": "20200604"}], "brand_name": "Xiidra", "product_id": "0078-0911_3cabbaea-c2bf-971c-e063-6394a90a4931", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]", "Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]"], "product_ndc": "0078-0911", "generic_name": "Lifitegrast", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Xiidra", "active_ingredients": [{"name": "LIFITEGRAST", "strength": "50 mg/mL"}], "application_number": "NDA208073", "marketing_category": "NDA", "marketing_start_date": "20160711", "listing_expiration_date": "20261231"}