FDA.reportPublic FDA data

LASTACAFT

Product NDC
0023-4291
11-digit product format
000234291
Labeler code
0023
Product ID
0023-4291_447257d6-c313-499e-8a48-499badb37766
Type
HUMAN OTC DRUG
Nonproprietary name
alcaftadine
Dosage form
SOLUTION/ DROPS
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
NDA022134
Marketing category
NDA
Marketing start
2021-12-01
Substance
ALCAFTADINE
Active strength
2.5 mg/mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALCAFTADINE2.5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7Z8O94ECSX
Rxcui1000085, 1000089

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-4291-01LASTACAFT1 in 1 CARTONSOLUTION/ DROPS14
0023-4291-01LASTACAFT1 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS14
0023-4291-05LASTACAFT1 in 1 CARTONSOLUTION/ DROPS14
0023-4291-05LASTACAFT5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54
0023-4291-06LASTACAFT5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54
0023-4291-06LASTACAFT1 in 1 CARTONSOLUTION/ DROPS14
0023-4291-07LASTACAFT5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54
0023-4291-07LASTACAFT2 in 1 CARTONSOLUTION/ DROPS24
0023-4291-10LASTACAFT2 in 1 CARTONSOLUTION/ DROPS24
0023-4291-10LASTACAFT5 mL in 1 BOTTLE, PLASTICSOLUTION/ DROPS54

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-4291-05ML - Milliliter0023-429158343e47-47f7-4c65-9ef9-e3d340c8e6f212022-02-07
0023-4291-10ML - Milliliter0023-42918662c004-68f5-4800-ac70-15cbb107bdef12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-4291LASTACAFT (ALCAFTADINE) SOLUTION/ DROPS [ALLERGAN, INC.]4Current NDC, Legacy NDC, 10 package rows20250215_a3002410-4bf1-4182-9d7c-8193eb7cd215.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1000085alcaftadine 0.25 % Ophthalmic SolutionPSNa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000089LASTACAFT 0.25 % Ophthalmic SolutionPSNa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000089alcaftadine 2.5 MG/ML Ophthalmic Solution [Lastacaft]SBDa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000085alcaftadine 2.5 MG/ML Ophthalmic SolutionSCDa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000085alcaftadine 0.25 % Ophthalmic SolutionSYa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000089Lastacaft 0.25 % Ophthalmic SolutionSYa3002410-4bf1-4182-9d7c-8193eb7cd2154
1000089Lastacaft 2.5 MG/ML Ophthalmic SolutionSYa3002410-4bf1-4182-9d7c-8193eb7cd2154

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0023-4291-01000234291011 BOTTLE, PLASTIC in 1 CARTON (0023-4291-01) / 1 mL in 1 BOTTLE, PLASTIC2021-12-010000-00-00YesNoCurrent
0023-4291-05000234291051 BOTTLE, PLASTIC in 1 CARTON (0023-4291-05) / 5 mL in 1 BOTTLE, PLASTIC2021-12-010000-00-00NoNoCurrent
0023-4291-06000234291061 BOTTLE, PLASTIC in 1 CARTON (0023-4291-06) / 5 mL in 1 BOTTLE, PLASTIC2021-12-010000-00-00NoNoCurrent
0023-4291-07000234291072 BOTTLE, PLASTIC in 1 CARTON (0023-4291-07) / 5 mL in 1 BOTTLE, PLASTIC2021-12-010000-00-00NoNoCurrent
0023-4291-10000234291102 BOTTLE, PLASTIC in 1 CARTON (0023-4291-10) / 5 mL in 1 BOTTLE, PLASTIC2021-12-010000-00-00NoNoCurrent