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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N022134-001LASTACAFTALCAFTADINE0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022134-001106176952027-03-19U-3267Drug product2020-05-12
N022134-00186642152027-12-23U-32672014-03-21

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-2831067a03dcf5…
2025-08-23 18:47 UTC2025-08N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-286a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-2803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-282680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-285bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-2879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-281e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-288072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-285c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-285d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-284b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-2874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-2887673890dc5c…
2021-03-12 10:30 UTC2021-03N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-285aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-288869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-283f01610625f2…
2019-09-15 20:21 UTC2019-09N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28b00525d2431f…
2019-07-19 19:46 UTC2019-07N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-286a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-281c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-289b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-283f0d92c62455…
2023-05-13 08:27 UTC2023-05N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28053a50430f4f…
2023-01-26 05:58 UTC2023-01N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-283bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-283a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022134-001LASTACAFT0.25%SOLUTION/DROPS / OPHTHALMICRLD, RS2010-07-28cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 78 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022134-001106176952027-03-19U-3267Drug product2020-05-12011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022134-00186642152027-12-23U-32672014-03-21011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022134-001106176952027-03-19U-3267Drug product2020-05-1231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022134-00186642152027-12-23U-32672014-03-2131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022134-001106176952027-03-19U-3267Drug product2020-05-126a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022134-00186642152027-12-23U-32672014-03-216a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022134-001106176952027-03-19U-3267Drug product2020-05-12fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022134-00186642152027-12-23U-32672014-03-21fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022134-001106176952027-03-19U-3267Drug product2020-05-12b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022134-00186642152027-12-23U-32672014-03-21b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022134-001106176952027-03-19U-3267Drug product2020-05-1203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022134-00186642152027-12-23U-32672014-03-2103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022134-001106176952027-03-19U-3267Drug product2020-05-122680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022134-00186642152027-12-23U-32672014-03-212680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022134-001106176952027-03-19U-3267Drug product2020-05-125bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022134-00186642152027-12-23U-32672014-03-215bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022134-001106176952027-03-19U-3267Drug product2020-05-12d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022134-00186642152027-12-23U-32672014-03-21d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022134-001106176952027-03-19U-3267Drug product2020-05-12d06236e962d9…
2024-10-29 15:01 UTC2024-10N022134-00186642152027-12-23U-32672014-03-21d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022134-001106176952027-03-19U-3267Drug product2020-05-1279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022134-00186642152027-12-23U-32672014-03-2179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022134-001106176952027-03-19U-3267Drug product2020-05-12301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022134-00186642152027-12-23U-32672014-03-21301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022134-001106176952027-03-19U-3267Drug product2020-05-121e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022134-00186642152027-12-23U-32672014-03-211e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022134-001106176952027-03-19U-3267Drug product2020-05-128072bd15b7f6…
2024-05-31 18:47 UTC2024-05N022134-00186642152027-12-23U-32672014-03-218072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022134-001106176952027-03-19U-3267Drug product2020-05-125c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022134-00186642152027-12-23U-32672014-03-215c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022134-001106176952027-03-19U-3267Drug product2020-05-125d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N022134-00186642152027-12-23U-32672014-03-215d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022134-001106176952027-03-19U-3267Drug product2020-05-124b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N022134-00186642152027-12-23U-32672014-03-214b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022134-00186642152027-12-23U-14932014-03-2174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022134-001106176952027-03-19U-3267Drug product2020-05-12bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N022134-00186642152027-12-23U-32672014-03-21bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022134-001106176952027-03-19U-1493Drug product2020-05-12782e0a99824c…
2021-12-28 21:50 UTC2021-12N022134-00186642152027-12-23U-14932014-03-21782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022134-001106176952027-03-19U-1493Drug product2020-05-1287673890dc5c…

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
7Z8O94ECSXInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1000085Internal RxNorm lookup
1000089Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
a3002410-4bf1-4182-9d7c-8193eb7cd215Available on FDA.report

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

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LASTACAFTALCAFTADINEAllergan, Inc.a3002410-4bf1-4182-9d7c-8193eb7cd2152022-08-10WarningsExact identifier
application applno (NDA): 022134
application number: NDA022134
ndc (product): 0023-4291
LASTACAFTALCAFTADINEAllergan, Inc.17d37e8d-7825-424b-b6ca-0a85d0bf46942020-06-01Warnings, Adverse reactionsExact identifier
application applno (NDA): 022134
application number: NDA022134

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