LOTEMAX

Product NDC: 24208-299
11-digit product format: 242080299
Labeler code: 24208
Product ID: 24208-299_ef44228f-e365-4d7f-b143-529257efffbe
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loteprednol etabonate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA020583
Marketing category: NDA
Marketing start: 1998-03-09
Substance: LOTEPREDNOL ETABONATE
Active strength: 5 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 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…`

Additional Listing Data#

Finished product: Yes
Brand name base: LOTEMAX
Listing expiration: 2026-12-31

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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213263	Internal RxNorm lookup
311382	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f37d74ac-5f9c-40a8-b43b-35148fc66bbe	Available on FDA.report

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
24208-299-01	LOTEMAX	1 mL in 1 BOTTLE	SUSPENSION/ DROPS	1	12
24208-299-01	LOTEMAX	1 in 1 CARTON	SUSPENSION/ DROPS	1	12
24208-299-05	LOTEMAX	5 mL in 1 BOTTLE	SUSPENSION/ DROPS	5	12
24208-299-05	LOTEMAX	1 in 1 CARTON	SUSPENSION/ DROPS	1	12
24208-299-10	LOTEMAX	10 mL in 1 BOTTLE	SUSPENSION/ DROPS	10	12
24208-299-10	LOTEMAX	1 in 1 CARTON	SUSPENSION/ DROPS	1	12
24208-299-15	LOTEMAX	15 mL in 1 BOTTLE	SUSPENSION/ DROPS	15	12
24208-299-15	LOTEMAX	1 in 1 CARTON	SUSPENSION/ DROPS	1	12

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-299-05	ML - Milliliter	24208-299	83fe4071-b171-4a36-8da1-4e84ddbb90ef	1	2012-07-24
24208-299-10	ML - Milliliter	24208-299	24043a5b-d282-4139-a4d3-b7ea50ec2b19	1	2012-07-24
24208-299-15	ML - Milliliter	24208-299	ba93e927-64b3-4538-9559-72610a755ed0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOTEPREDNOL ETABONATE	ACTIVE INGREDIENT	YEH1EZ96K6	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
LOTEPREDNOL	ACTIVE MOIETY	Z8CBU6KR16	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	7
LOTEPREDNOL ETABONATE	ACTIVE INGREDIENT	YEH1EZ96K6	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
LOTEPREDNOL ETABONATE	ACTIVE MOIETY	YEH1EZ96K6	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-299	LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	12	Current NDC, Legacy NDC, 8 package rows	20230630_f37d74ac-5f9c-40a8-b43b-35148fc66bbe.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 ndc (product): 24208-299

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
213263	Lotemax 0.5 % Ophthalmic Suspension	PSN	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	PSN	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
213263	loteprednol etabonate 5 MG/ML Ophthalmic Suspension [Lotemax]	SBD	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
311382	loteprednol etabonate 5 MG/ML Ophthalmic Suspension	SCD	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
213263	Lotemax 0.5 % Ophthalmic Suspension	SY	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
213263	Lotemax 5 MG/ML Ophthalmic Suspension	SY	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	SY	f37d74ac-5f9c-40a8-b43b-35148fc66bbe	12
213263	Lotemax 0.5 % Ophthalmic Suspension	PSN	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	PSN	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
213263	loteprednol etabonate 5 MG/ML Ophthalmic Suspension [Lotemax]	SBD	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
311382	loteprednol etabonate 5 MG/ML Ophthalmic Suspension	SCD	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
213263	Lotemax 0.5 % Ophthalmic Suspension	SY	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
213263	Lotemax 5 MG/ML Ophthalmic Suspension	SY	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1
311382	loteprednol etabonate 0.5 % Ophthalmic Suspension	SY	e7ae762f-5e0b-4f64-9323-8f44db2c0b4c	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-299-01	24208029901	1 BOTTLE in 1 CARTON (24208-299-01) / 1 mL in 1 BOTTLE	1 bottle	2020-12-15	0000-00-00	Yes	No	Current
24208-299-05	24208029905	1 BOTTLE in 1 CARTON (24208-299-05) / 5 mL in 1 BOTTLE	1 bottle	1998-09-03	0000-00-00	No	No	Current
24208-299-10	24208029910	1 BOTTLE in 1 CARTON (24208-299-10) / 10 mL in 1 BOTTLE	1 bottle	1998-09-03	0000-00-00	No	No	Current
24208-299-15	24208029915	1 BOTTLE in 1 CARTON (24208-299-15) / 15 mL in 1 BOTTLE	1 bottle	1998-09-03	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Lotemax ® loteprednol etabonate ophthalmic suspension 0.5% STERILE OPHTHALMIC SUSPENSION Rx only	Bausch & Lomb Incorporated	2023-04-17	HUMAN PRESCRIPTION DRUG LABEL	12
LOTEMAX® loteprednol etabonate ophthalmic suspension, 0.5%	Physicians Total Care, Inc.	2010-04-05	HUMAN PRESCRIPTION DRUG LABEL	1