Home NDC 68083-649 Alcaftadine
Product NDC 68083-649
11-digit product format 680830649
Labeler code 68083
Product ID 68083-649_8c937f90-5ae8-49e9-808d-f3dbd9da1882
Type HUMAN OTC DRUG
Nonproprietary name Alcaftadine
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Gland Pharma Limited
Application ANDA209706
Marketing category ANDA
Marketing start 2024-03-01
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 43 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date A209706-001 ALCAFTADINE ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01
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.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-09-14 22:38:34 2026-08 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 84e616aacf4f…2026-08-18 06:07:40 2026-07 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 6a51e52b5d6a…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A209706-001 ALCAFTADINE 0.25% SOLUTION/DROPS / OPHTHALMIC 2024-03-01 a50c72e98297…
Additional Listing Data#
Finished product Yes
Brand name base Alcaftadine
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ALCAFTADINE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7Z8O94ECSX Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1000085 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68083-649-01 Alcaftadine 1 in 1 CARTON SOLUTION/ DROPS 1 3 68083-649-01 Alcaftadine 3 mL in 1 BOTTLE SOLUTION/ DROPS 3 3 68083-649-02 Alcaftadine 2 in 1 CARTON SOLUTION/ DROPS 2 3 68083-649-02 Alcaftadine 3 mL in 1 BOTTLE SOLUTION/ DROPS 3 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68083-649 ALCAFTADINE SOLUTION/ DROPS [GLAND PHARMA LIMITED] 3 Current NDC, 4 package rows 20240307_b94e071d-421d-48ec-a4ea-254aa8af19ff.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 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68083-649-01 68083064901 1 BOTTLE in 1 CARTON (68083-649-01) / 3 mL in 1 BOTTLE 1 bottle 2024-03-01 No No Current 68083-649-02 68083064902 2 BOTTLE in 1 CARTON (68083-649-02) / 3 mL in 1 BOTTLE 2 bottle 2024-03-01 No No Current