Alrex

Product NDC: 24208-353
11-digit product format: 242080353
Labeler code: 24208
Product ID: 24208-353_138577af-1a4e-48fb-b088-47f54c896442
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: loteprednol etabonate
Dosage form: SUSPENSION/ DROPS
Route: OPHTHALMIC
Labeler: Bausch & Lomb Incorporated
Application: NDA020803
Marketing category: NDA
Marketing start: 1998-03-09
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
N020803-001	ALREX	LOTEPREDNOL ETABONATE	0.2%	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
N020803-001	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 · 42 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
2026-08-18 06:07:40	2026-07	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC	AB	RLD, RS	1998-03-09	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N020803-001	ALREX	0.2%	SUSPENSION/DROPS / OPHTHALMIC		RLD, RS	1998-03-09	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	N020803-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020803-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020803-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020803-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020803-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020803-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020803-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020803-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020803-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020803-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020803-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020803-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020803-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020803-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020803-001	AB	1	`8072bd15b7f6…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020803-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020803-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020803-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020803-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020803-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020803-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020803-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020803-001	AB	1	`053a50430f4f…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N020803-001	AB	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Alrex
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 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
213262	Internal RxNorm lookup
311381	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
21c76da0-50a1-41c0-91b8-8cc4dcc27f60	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
24208-353-01	Alrex	1 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	1	14
24208-353-01	Alrex	1 in 1 CARTON	SUSPENSION/ DROPS	1	14
24208-353-05	Alrex	5 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	5	14
24208-353-05	Alrex	1 in 1 CARTON	SUSPENSION/ DROPS	1	14
24208-353-10	Alrex	10 mL in 1 BOTTLE, DROPPER	SUSPENSION/ DROPS	10	14
24208-353-10	Alrex	1 in 1 CARTON	SUSPENSION/ DROPS	1	14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
24208-353-05	ML - Milliliter	24208-353	a8cf8d1f-4f47-4169-b721-d86328946efd	1	2012-07-24
24208-353-10	ML - Milliliter	24208-353	09ed44c8-dbe5-45af-8715-7616c3c9533e	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LOTEPREDNOL ETABONATE	ACTIVE INGREDIENT	YEH1EZ96K6	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
LOTEPREDNOL	ACTIVE MOIETY	Z8CBU6KR16	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
POVIDONES	INACTIVE INGREDIENT	FZ989GH94E	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	8
LOTEPREDNOL ETABONATE	ACTIVE INGREDIENT	YEH1EZ96K6	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
LOTEPREDNOL	ACTIVE MOIETY	Z8CBU6KR16	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]	2
LOTEPREDNOL ETABONATE	ACTIVE INGREDIENT	YEH1EZ96K6	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
LOTEPREDNOL	ACTIVE MOIETY	Z8CBU6KR16	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
POVIDONE	INACTIVE INGREDIENT	FZ989GH94E	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
TYLOXAPOL	INACTIVE INGREDIENT	Y27PUL9H56	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	ALREX (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
24208-353	ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]	14	Current NDC, Legacy NDC, 6 package rows	20220526_21c76da0-50a1-41c0-91b8-8cc4dcc27f60.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.	7714824b-29ed-442a-ad2d-13ee2fc6bc42	2026-02-07	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020803 application number: NDA020803
Alrex	LOTEPREDNOL ETABONATE	Bausch & Lomb Incorporated	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	2022-03-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 020803 application number: NDA020803 ndc (product): 24208-353

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
213262	Alrex 0.2 % Ophthalmic Suspension	PSN	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	PSN	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
213262	loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]	SBD	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
311381	loteprednol etabonate 2 MG/ML Ophthalmic Suspension	SCD	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
213262	Alrex 0.2 % Ophthalmic Suspension	SY	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
213262	Alrex 2 MG/ML Ophthalmic Suspension	SY	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	SY	21c76da0-50a1-41c0-91b8-8cc4dcc27f60	14
213262	Alrex 0.2 % Ophthalmic Suspension	PSN	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	PSN	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
213262	loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]	SBD	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
311381	loteprednol etabonate 2 MG/ML Ophthalmic Suspension	SCD	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
213262	Alrex 0.2 % Ophthalmic Suspension	SY	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
213262	Alrex 2 MG/ML Ophthalmic Suspension	SY	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	SY	cf290d54-26a1-4d22-8cb8-852bdc7b5280	2
213262	Alrex 0.2 % Ophthalmic Suspension	PSN	95188fb4-03b6-46ac-a601-41cb82ebde40	1
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	PSN	95188fb4-03b6-46ac-a601-41cb82ebde40	1
213262	loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]	SBD	95188fb4-03b6-46ac-a601-41cb82ebde40	1
311381	loteprednol etabonate 2 MG/ML Ophthalmic Suspension	SCD	95188fb4-03b6-46ac-a601-41cb82ebde40	1
213262	Alrex 0.2 % Ophthalmic Suspension	SY	95188fb4-03b6-46ac-a601-41cb82ebde40	1
213262	Alrex 2 MG/ML Ophthalmic Suspension	SY	95188fb4-03b6-46ac-a601-41cb82ebde40	1
311381	loteprednol etabonate 0.2 % Ophthalmic Suspension	SY	95188fb4-03b6-46ac-a601-41cb82ebde40	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
24208-353-01	24208035301	1 BOTTLE, DROPPER in 1 CARTON (24208-353-01) / 1 mL in 1 BOTTLE, DROPPER	1998-03-09	0000-00-00	Yes	No	Current
24208-353-05	24208035305	1 BOTTLE, DROPPER in 1 CARTON (24208-353-05) / 5 mL in 1 BOTTLE, DROPPER	1998-03-09	0000-00-00	No	No	Current
24208-353-10	24208035310	1 BOTTLE, DROPPER in 1 CARTON (24208-353-10) / 10 mL in 1 BOTTLE, DROPPER	1998-03-09	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Alrex ® (loteprednol etabonate ophthalmic suspension, 0.2%) STERILE OPHTHALMIC SUSPENSION	Bausch & Lomb Incorporated	2022-03-31	HUMAN PRESCRIPTION DRUG LABEL	14
ALREX loteprednol etabonate ophthalmic suspension, 0.2%	STAT Rx USA LLC \| PSS World Medical Inc.	2012-09-18	HUMAN PRESCRIPTION DRUG LABEL	2
ALREX loteprednol etabonate ophthalmic suspension, 0.2%	Physicians Total Care, Inc.	2012-09-10	HUMAN PRESCRIPTION DRUG LABEL	1