Lotemax

Product NDC: 24208-443
11-digit product format: 242080443
Labeler code: 24208
Product ID: 24208-443_b1d6fda8-73c9-478f-addd-14949e0454e4
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loteprednol etabonate
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA200738
Marketing category: NDA
Marketing start: 2011-04-15
Substance: LOTEPREDNOL ETABONATE
Active strength: 5 mg/g
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
N200738-001	LOTEMAX	LOTEPREDNOL ETABONATE	0.5%	OINTMENT / OPHTHALMIC		RLD, RS	2011-04-15

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 · 42 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-08-18 06:07:40	2026-07	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N200738-001	LOTEMAX	0.5%	OINTMENT / OPHTHALMIC	RLD, RS	2011-04-15	`e64feba35796…`

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/g

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
1099500	Internal RxNorm lookup
1099503	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
902a3c6b-2625-44ec-a077-926e012b3176	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
24208-443-01	Lotemax	1.0 g in 1 TUBE	OINTMENT	1.0	17
24208-443-01	Lotemax	1 in 1 CARTON	OINTMENT	1	17
24208-443-35	Lotemax	3.5 g in 1 TUBE	OINTMENT	3.5	17
24208-443-35	Lotemax	1 in 1 CARTON	OINTMENT	1	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-443-35	GM - Gram	24208-443	093f3f1d-b340-4a4e-b747-462dc00ff0ce	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) OINTMENT [BAUSCH & LOMB INCORPORATED]	11
LOTEPREDNOL	ACTIVE MOIETY	Z8CBU6KR16	LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]	11
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]	11
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]	11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
24208-443	LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]	17	Current NDC, Legacy NDC, 4 package rows	20230401_902a3c6b-2625-44ec-a077-926e012b3176.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.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Lotemax	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	902a3c6b-2625-44ec-a077-926e012b3176	2022-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 200738 application number: NDA200738 ndc (product): 24208-443

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
1099503	LOTEMAX 0.5 % Ophthalmic Ointment	PSN	902a3c6b-2625-44ec-a077-926e012b3176	17
1099500	loteprednol etabonate 0.5 % Ophthalmic Ointment	PSN	902a3c6b-2625-44ec-a077-926e012b3176	17
1099503	loteprednol etabonate 0.005 MG/MG Ophthalmic Ointment [Lotemax]	SBD	902a3c6b-2625-44ec-a077-926e012b3176	17
1099500	loteprednol etabonate 0.005 MG/MG Ophthalmic Ointment	SCD	902a3c6b-2625-44ec-a077-926e012b3176	17
1099503	Lotemax 0.005 MG/MG Ophthalmic Ointment	SY	902a3c6b-2625-44ec-a077-926e012b3176	17
1099503	Lotemax 0.5 % Ophthalmic Ointment	SY	902a3c6b-2625-44ec-a077-926e012b3176	17
1099500	loteprednol etabonate 0.5 % Ophthalmic Ointment	SY	902a3c6b-2625-44ec-a077-926e012b3176	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-443-01	24208044301	1 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE	1 tube	2011-04-15	0000-00-00	Yes	No	Current
24208-443-35	24208044335	1 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE	1 tube	2011-04-15	0000-00-00	No	No	Current