Home NDC 62756-232 Loteprednol Etabonate
Product NDC 62756-232
11-digit product format 627560232
Labeler code 62756
Product ID 62756-232_5911e66e-1d2c-489b-bae8-415c74fd9d88
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Loteprednol Etabonate
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Sun Pharmaceutical Industries, Inc.
Application ANDA212450
Marketing category ANDA
Marketing start 2021-05-01
Marketing end 2026-12-31
Substance LOTEPREDNOL ETABONATE
Active strength 5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
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 A212450-001 LOTEPREDNOL ETABONATE LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A212450-001 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 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 4b0b4de00fa7…2022-03-09 01:35 UTC 2022-03 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 87673890dc5c…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 e64feba35796…2022-07-09 03:26 UTC · 3 captures of this ZIP 2022-07 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 cb3db0bc1861…2026-07-26 02:55 UTC · 3 captures of this ZIP 2026-06 A212450-001 LOTEPREDNOL ETABONATE 0.5% SUSPENSION/DROPS / OPHTHALMIC AB 2021-02-26 a50c72e98297…
Observed Orange Book normalized TE history# Observed Orange Book exclusivity history# Captured, Edition, Application-product table Captured Edition Application-product Exclusivity code Expiration Source SHA-256 2021-12-28 21:50 UTC 2021-12 A212450-001 CGT 2021-11-02 782e0a99824c…
Additional Listing Data#
Finished product Yes
Brand name base Loteprednol Etabonate Active Ingredients# Ingredient, Strength table Ingredient Strength LOTEPREDNOL ETABONATE 5 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 311382 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 62756-232-55 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 3 62756-232-55 Loteprednol Etabonate 10 mL in 1 BOTTLE SUSPENSION/ DROPS 10 3 62756-232-56 Loteprednol Etabonate 15 mL in 1 BOTTLE SUSPENSION/ DROPS 15 3 62756-232-56 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 3 62756-232-90 Loteprednol Etabonate 1 in 1 CARTON SUSPENSION/ DROPS 1 3 62756-232-90 Loteprednol Etabonate 5 mL in 1 BOTTLE SUSPENSION/ DROPS 5 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 62756-232 LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.] 2 Current NDC, Legacy NDC, 6 package rows 20210501_36cfd5b8-c892-44e1-aaed-fb32d7aeca7c.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 62756-232-55 62756023255 1 BOTTLE in 1 CARTON (62756-232-55) / 10 mL in 1 BOTTLE 1 bottle 2021-05-01 0000-00-00 No No Current 62756-232-56 62756023256 1 BOTTLE in 1 CARTON (62756-232-56) / 15 mL in 1 BOTTLE 1 bottle 2021-05-01 0000-00-00 No No Current 62756-232-90 62756023290 1 BOTTLE in 1 CARTON (62756-232-90) / 5 mL in 1 BOTTLE 1 bottle 2021-05-01 0000-00-00 No No Current