Home NDC 72485-653 Loteprednol Etabonate
Product NDC 72485-653
11-digit product format 724850653
Labeler code 72485
Product ID 72485-653_1a784c5a-bdb4-c5b8-e063-6394a90a8f9c
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loteprednol Etabonate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler ARMAS PHARMACEUTICALS INC.
Application ANDA215933
Marketing category ANDA
Marketing start 2023-10-24
Substance LOTEPREDNOL ETABONATE
Active strength 2 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [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 42 .
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 A215933-001 LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A215933-001 AB
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 2026-08-18 06:07:40 2026-07 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 8072bd15b7f6…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 053a50430f4f…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A215933-001 LOTEPREDNOL ETABONATE 0.2% SUSPENSION/DROPS / OPHTHALMIC AB 2023-04-12 a50c72e98297…
Observed Orange Book normalized TE history# Additional Listing Data#
Finished product Yes
Brand name base Loteprednol Etabonate
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 2 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination YEH1EZ96K6 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 311381 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 72485-653-05 Loteprednol Etabonate 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 2 72485-653-05 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 2 72485-653-10 Loteprednol Etabonate 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 2 72485-653-10 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 72485-653 LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [ARMAS PHARMACEUTICALS INC.] 2 Current NDC, 4 package rows 20240611_36c05fa4-6562-4af8-86ac-e79003ee65dd.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 · 3 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 72485-653-05 72485065305 1 BOTTLE, DROPPER in 1 CARTON (72485-653-05) / 5 mL in 1 BOTTLE, DROPPER 2023-10-24 No No Current 72485-653-10 72485065310 1 BOTTLE, DROPPER in 1 CARTON (72485-653-10) / 10 mL in 1 BOTTLE, DROPPER 2023-10-24 No No Current