Loteprednol Etabonate

Product NDC: 68682-299
11-digit product format: 686820299
Labeler code: 68682
Product ID: 68682-299_4fae2525-e16d-8c0f-e063-6294a90a143b
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loteprednol etabonate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Oceanside Pharmaceuticals
Application: NDA020583
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2019-07-01
Marketing end: 2026-05-31
Substance: LOTEPREDNOL ETABONATE
Active strength: 5 mg/mL
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Current FDA listing: Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	68682-299		D	Discontinued by firm	2026-08-10
excluded package	package	68682-299	68682-299-05	D	Discontinued by firm	2026-08-10
excluded package	package	68682-299	68682-299-10	D	Discontinued by firm	2026-08-10
excluded package	package	68682-299	68682-299-15	D	Discontinued by firm	2026-08-10

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020583-001	LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020583-001	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.

Product history page 1 of 2 · 41 observed 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
2026-02-19 14:30 UTC	2026-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020583-001	LOTEMAX	0.5%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N020583-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020583-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020583-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020583-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020583-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020583-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020583-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020583-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020583-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020583-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020583-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020583-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020583-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020583-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020583-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020583-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020583-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020583-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020583-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020583-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020583-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020583-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020583-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020583-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020583-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020583-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020583-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020583-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020583-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020583-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020583-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020583-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020583-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020583-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020583-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020583-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020583-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020583-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020583-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N020583-001	AB	1	`cb3db0bc1861…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
4f474382-f6ee-e00d-5df3-bba50cddfd89	Product name	5	20251114
64ba4d79-5363-eefc-3390-ee5d2a50a350	Product name	3	20250304
100e83dc-ec8c-9e2e-76d2-5112415ec972	Product name	3	20241008
4300453c-d545-46d1-b115-18b12b4ccf79	Product name	1	20210525
3f316f1c-2561-47c9-9865-ba2be69e0b3e	Product name	1	20190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35	Product name	1	20181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81	Product name	1	20140508
b5c5cd73-a27b-5e41-bd36-3de9471473cd	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68682-299-05	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	3
68682-299-05	Loteprednol Etabonate	5 mL in 1 BOTTLE	SUSPENSION/ DROPS	5	3
68682-299-10	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	3
68682-299-10	Loteprednol Etabonate	10 mL in 1 BOTTLE	SUSPENSION/ DROPS	10	3
68682-299-15	Loteprednol Etabonate	1 in 1 CARTON	SUSPENSION/ DROPS	1	3
68682-299-15	Loteprednol Etabonate	15 mL in 1 BOTTLE	SUSPENSION/ DROPS	15	3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
68682-299-05	ML - Milliliter	68682-299	d5410b33-cd30-45da-947e-a2ba72ac1a72	1	2019-08-06
68682-299-10	ML - Milliliter	68682-299	8b98ee04-b5d2-4a98-97e6-4e34b9874655	1	2019-08-06
68682-299-15	ML - Milliliter	68682-299	d56064b0-d72c-448b-9e5e-5a009926fc16	1	2019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68682-299	LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [OCEANSIDE PHARMACEUTICALS]	2	Current NDC, Legacy NDC, 6 package rows	20200825_f9edfd73-e1b1-44e4-8e7c-90b0c2fa204d.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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Loteprednol Etabonate	LOTEPREDNOL ETABONATE	Bausch & Lomb Americas Inc.	f09b1206-97c7-4f21-bda8-94f55128c5cb	2025-03-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020583 application number: NDA020583
LOTEMAX	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	2023-04-17	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020583 application number: NDA020583

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
YEH1EZ96K6	LOTEPREDNOL ETABONATE	82034-46-6	LOTEPREDNOL ETABONATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68682-299-05	68682029905	1 BOTTLE in 1 CARTON (68682-299-05) > 5 mL in 1 BOTTLE	1 bottle	2019-07-01	0000-00-00	No	No	Current
68682-299-10	68682029910	1 BOTTLE in 1 CARTON (68682-299-10) / 10 mL in 1 BOTTLE	1 bottle	2019-07-01	2026-05-31	No	No	Current
68682-299-15	68682029915	1 BOTTLE in 1 CARTON (68682-299-15) > 15 mL in 1 BOTTLE	1 bottle	2019-07-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Loteprednol Etabonate Ophthalmic Suspension 0.5%	Oceanside Pharmaceuticals \| Bausch & Lomb Incorporated	2026-04-17	HUMAN PRESCRIPTION DRUG LABEL	3
Loteprednol Etabonate Ophthalmic Suspension 0.5%	Bryant Ranch Prepack	2024-03-21	HUMAN PRESCRIPTION DRUG LABEL	100