FDA.reportPublic FDA data

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui213262, 311381

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4f474382-f6ee-e00d-5df3-bba50cddfd89Product name520251114
64ba4d79-5363-eefc-3390-ee5d2a50a350Product name320250304
100e83dc-ec8c-9e2e-76d2-5112415ec972Product name320241008
4300453c-d545-46d1-b115-18b12b4ccf79Product name120210525
3f316f1c-2561-47c9-9865-ba2be69e0b3eProduct name120190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35Product name120181206
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b5c5cd73-a27b-5e41-bd36-3de9471473cdProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24208-353-01Alrex1 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS114
24208-353-01Alrex1 in 1 CARTONSUSPENSION/ DROPS114
24208-353-05Alrex5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS514
24208-353-05Alrex1 in 1 CARTONSUSPENSION/ DROPS114
24208-353-10Alrex10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS1014
24208-353-10Alrex1 in 1 CARTONSUSPENSION/ DROPS114

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-353-05ML - Milliliter24208-353a8cf8d1f-4f47-4169-b721-d86328946efd12012-07-24
24208-353-10ML - Milliliter24208-35309ed44c8-dbe5-45af-8715-7616c3c9533e12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
LOTEPREDNOLACTIVE MOIETYZ8CBU6KR16ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
POVIDONESINACTIVE INGREDIENTFZ989GH94EALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
WATERINACTIVE INGREDIENT059QF0KO0RALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]8
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
LOTEPREDNOLACTIVE MOIETYZ8CBU6KR16ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
POVIDONEINACTIVE INGREDIENTFZ989GH94EALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [STAT RX USA LLC]2
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
LOTEPREDNOLACTIVE MOIETYZ8CBU6KR16ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94EALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-353ALREX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]14Current NDC, Legacy NDC, 6 package rows20220526_21c76da0-50a1-41c0-91b8-8cc4dcc27f60.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213262Alrex 0.2 % Ophthalmic SuspensionPSN21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionPSN21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
213262loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]SBD21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
311381loteprednol etabonate 2 MG/ML Ophthalmic SuspensionSCD21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
213262Alrex 0.2 % Ophthalmic SuspensionSY21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
213262Alrex 2 MG/ML Ophthalmic SuspensionSY21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionSY21c76da0-50a1-41c0-91b8-8cc4dcc27f6014
213262Alrex 0.2 % Ophthalmic SuspensionPSNcf290d54-26a1-4d22-8cb8-852bdc7b52802
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionPSNcf290d54-26a1-4d22-8cb8-852bdc7b52802
213262loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]SBDcf290d54-26a1-4d22-8cb8-852bdc7b52802
311381loteprednol etabonate 2 MG/ML Ophthalmic SuspensionSCDcf290d54-26a1-4d22-8cb8-852bdc7b52802
213262Alrex 0.2 % Ophthalmic SuspensionSYcf290d54-26a1-4d22-8cb8-852bdc7b52802
213262Alrex 2 MG/ML Ophthalmic SuspensionSYcf290d54-26a1-4d22-8cb8-852bdc7b52802
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionSYcf290d54-26a1-4d22-8cb8-852bdc7b52802
213262Alrex 0.2 % Ophthalmic SuspensionPSN95188fb4-03b6-46ac-a601-41cb82ebde401
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionPSN95188fb4-03b6-46ac-a601-41cb82ebde401
213262loteprednol etabonate 2 MG/ML Ophthalmic Suspension [Alrex]SBD95188fb4-03b6-46ac-a601-41cb82ebde401
311381loteprednol etabonate 2 MG/ML Ophthalmic SuspensionSCD95188fb4-03b6-46ac-a601-41cb82ebde401
213262Alrex 0.2 % Ophthalmic SuspensionSY95188fb4-03b6-46ac-a601-41cb82ebde401
213262Alrex 2 MG/ML Ophthalmic SuspensionSY95188fb4-03b6-46ac-a601-41cb82ebde401
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionSY95188fb4-03b6-46ac-a601-41cb82ebde401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
24208-353-01242080353011 BOTTLE, DROPPER in 1 CARTON (24208-353-01) / 1 mL in 1 BOTTLE, DROPPER1998-03-090000-00-00YesNoCurrent
24208-353-05242080353051 BOTTLE, DROPPER in 1 CARTON (24208-353-05) / 5 mL in 1 BOTTLE, DROPPER1998-03-090000-00-00NoNoCurrent
24208-353-10242080353101 BOTTLE, DROPPER in 1 CARTON (24208-353-10) / 10 mL in 1 BOTTLE, DROPPER1998-03-090000-00-00NoNoCurrent