NDC 54092-606

Xiidra

Lifitegrast

Xiidra is a Ophthalmic Solution/ Drops in the Human Prescription Drug category. It is labeled and distributed by Takeda Pharmaceuticals America, Inc.. The primary component is Lifitegrast.

• Product ID: 54092-606_2648ebbb-5b5e-4497-adc2-db90088ba884
• NDC: 54092-606
• Product Type: Human Prescription Drug
• Proprietary Name: Xiidra
• Generic Name: Lifitegrast
• Dosage Form: Solution/ Drops
• Route of Administration: OPHTHALMIC
• Marketing Start Date: 2016-07-11
• Marketing End Date: 2023-03-31
• Marketing Category: NDA / NDA
• Application Number: NDA208073
• Labeler Name: Takeda Pharmaceuticals America, Inc.
• Substance Name: LIFITEGRAST
• Active Ingredient Strength: 50 mg/mL
• Pharm Classes: Lymphocyte Function-Associated Antigen-1 Antagonist [EPC],Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]
• NDC Exclude Flag: N

Packaging

NDC 54092-606-01

12 POUCH in 1 CARTON (54092-606-01) > 5 AMPULE in 1 POUCH (54092-606-06) > .2 mL in 1 AMPULE

• Marketing Start Date: 2016-07-11
• Marketing End Date: 2023-02-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 54092-606-07 [54092060607]

Xiidra SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-11

NDC 54092-606-04 [54092060604]

Xiidra SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-11

NDC 54092-606-06 [54092060606]

Xiidra SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-11

NDC 54092-606-02 [54092060602]

Xiidra SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208073
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2016-07-11

NDC 54092-606-01 [54092060601]

Xiidra SOLUTION/ DROPS

• Marketing Category: NDA
• Application Number: NDA208073
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-07-11

Drug Details

Active Ingredients

Ingredient	Strength
LIFITEGRAST	50 mg/mL

OpenFDA Data

• SPL SET ID: ac09d19a-e321-4556-8a5c-66bd27cb6533
• Manufacturer:
  • Shire US Manufacturing Inc.
• UNII:
  • 038E5L962W
• RxNorm Concept Unique ID - RxCUI:
  • 1801835
  • 1801840

Pharmacological Class

• Lymphocyte Function-Associated Antigen-1 Antagonist [EPC]
• Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]

Medicade Reported Pricing

54092060601 XIIDRA 5% EYE DROPS

Pricing Unit: EA | Drug Type:

NDC Crossover Matching brand name "Xiidra" or generic name "Lifitegrast"

NDC	Brand Name	Generic Name
0078-0911	Xiidra	Lifitegrast
54092-606	Xiidra	Lifitegrast