Xiidra

Product NDC
24208-911
11-digit product format
242080911
Labeler code
24208
Product ID
24208-911_2770cd53-f66c-2097-e063-6394a90a874b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Lifitegrast
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA208073
Marketing category
NDA
Marketing start
2024-01-02
Substance
LIFITEGRAST
Active strength
50 mg/mL
Pharmacologic classes
Lymphocyte Function-Associated Antigen-1 Antagonist [EPC], Lymphocyte Function-Associated Antigen-1 Antagonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Xiidra
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIFITEGRAST50 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii038E5L962W
Rxcui1801835, 1801840

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
4073022c-5d5d-48f5-82ed-091ad146a4b2Product name120171211
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ef78cb32-15f8-4d2d-9107-ca3997b019cfProduct name120160819
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
9ffbd0ae-0bce-c086-b707-f0da5f8cd7c5Product name120150828
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-911-05Xiidra0.2 mL in 1 AMPULESOLUTION/ DROPS0.25
24208-911-05Xiidra5 in 1 POUCHSOLUTION/ DROPS55
24208-911-12Xiidra12 in 1 CARTONSOLUTION/ DROPS125
24208-911-94Xiidra4 in 1 CARTONSOLUTION/ DROPS45
24208-911-95Xiidra5 in 1 POUCHSOLUTION/ DROPS55
24208-911-95Xiidra0.2 mL in 1 AMPULESOLUTION/ DROPS0.25

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-911-05EA - Each24208-9114d791291-2155-4d98-b23e-ad28c5d1255512024-12-10
24208-911-12EA - Each24208-9114ef786d7-7691-454c-af08-d4ddc6de070d12024-12-10
24208-911-94EA - Each24208-911cf89329f-9421-4a1e-9bd5-0f0007a92d5e12025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-911XIIDRA (LIFITEGRAST) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]5Current NDC, 6 package rows20241123_1a914080-a3c0-44be-b601-0ae3160e77eb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1801835lifitegrast 5 % Ophthalmic SolutionPSN1a914080-a3c0-44be-b601-0ae3160e77eb5
1801840xiidra 5 % Ophthalmic SolutionPSN1a914080-a3c0-44be-b601-0ae3160e77eb5
1801840lifitegrast 50 MG/ML Ophthalmic Solution [Xiidra]SBD1a914080-a3c0-44be-b601-0ae3160e77eb5
1801835lifitegrast 50 MG/ML Ophthalmic SolutionSCD1a914080-a3c0-44be-b601-0ae3160e77eb5
1801835lifitegrast 5 % Ophthalmic SolutionSY1a914080-a3c0-44be-b601-0ae3160e77eb5
1801840xiidra 50 MG/ML Ophthalmic SolutionSY1a914080-a3c0-44be-b601-0ae3160e77eb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
24208-911-05242080911050.2 mL in 1 AMPULE0.2 mlHistorical
24208-911-122420809111212 POUCH in 1 CARTON (24208-911-12) / 5 AMPULE in 1 POUCH (24208-911-05) / .2 mL in 1 AMPULE12 pouch2024-01-02NoNoHistorical
24208-911-94242080911944 POUCH in 1 CARTON (24208-911-94) / 5 AMPULE in 1 POUCH (24208-911-95) / .2 mL in 1 AMPULE4 pouch2024-01-02YesNoHistorical
24208-911-95242080911955 in 1 POUCHHistorical