FDA.reportPublic FDA data

LASTACAFT

Product NDC
42254-288
11-digit product format
422540288
Labeler code
42254
Product ID
42254-288_4b8c6afe-2d76-46c7-a23e-99db5e180ff6
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
alcaftadine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Rebel Distributors Corp
Application
NDA022134
Marketing category
NDA
Marketing start
2010-11-01
Marketing end
0000-00-00
Substance
ALCAFTADINE
Active strength
3 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA],Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4b7a6bd5-956e-f134-86e5-d4d9706c15d4Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42254-288-032019-09-24C16284748780-19350213a-3c9b-c013-e053-90daa90a1393These highlights do not include all the information needed to use LASTACAFT ® safely and effectively. See full prescribing information for LASTACAFT ® . LASTACAFT ® (alcaftadine ophthalmic solution) 0.25% Initial U.S. Approval: 2010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42254-288-03LASTACAFT1 in 1 CARTONSOLUTION/ DROPS11
42254-288-03LASTACAFT3 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS31

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42254-288-03ML - Milliliter42254-288c48bafa0-8678-4a9d-b413-57319d6431bc12013-03-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
alcaftadineACTIVE INGREDIENT7Z8O94ECSXLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
alcaftadineACTIVE MOIETY7Z8O94ECSXLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
benzalkonium chlorideINACTIVE INGREDIENTF5UM2KM3W7LASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
hydrochloric acidINACTIVE INGREDIENTQTT17582CBLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
sodium chlorideINACTIVE INGREDIENT451W47IQ8XLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32ILASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
sodium phosphate, monobasicINACTIVE INGREDIENT3980JIH2SWLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1
waterINACTIVE INGREDIENT059QF0KO0RLASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42254-288LASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP]1Legacy NDC, 2 package rows20130228_4b8c6afe-2d76-46c7-a23e-99db5e180ff6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000085alcaftadine 0.25 % Ophthalmic SolutionPSN4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000089LASTACAFT 0.25 % Ophthalmic SolutionPSN4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000089alcaftadine 2.5 MG/ML Ophthalmic Solution [Lastacaft]SBD4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000085alcaftadine 2.5 MG/ML Ophthalmic SolutionSCD4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000085alcaftadine 0.25 % Ophthalmic SolutionSY4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000089Lastacaft 0.25 % Ophthalmic SolutionSY4b8c6afe-2d76-46c7-a23e-99db5e180ff61
1000089Lastacaft 2.5 MG/ML Ophthalmic SolutionSY4b8c6afe-2d76-46c7-a23e-99db5e180ff61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionStatus
42254-288-03422540288031 in 1 CARTONHistorical