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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui213263, 311382

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
24208-299-01LOTEMAX1 mL in 1 BOTTLESUSPENSION/ DROPS112
24208-299-01LOTEMAX1 in 1 CARTONSUSPENSION/ DROPS112
24208-299-05LOTEMAX5 mL in 1 BOTTLESUSPENSION/ DROPS512
24208-299-05LOTEMAX1 in 1 CARTONSUSPENSION/ DROPS112
24208-299-10LOTEMAX10 mL in 1 BOTTLESUSPENSION/ DROPS1012
24208-299-10LOTEMAX1 in 1 CARTONSUSPENSION/ DROPS112
24208-299-15LOTEMAX15 mL in 1 BOTTLESUSPENSION/ DROPS1512
24208-299-15LOTEMAX1 in 1 CARTONSUSPENSION/ DROPS112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-299-05ML - Milliliter24208-29983fe4071-b171-4a36-8da1-4e84ddbb90ef12012-07-24
24208-299-10ML - Milliliter24208-29924043a5b-d282-4139-a4d3-b7ea50ec2b1912012-07-24
24208-299-15ML - Milliliter24208-299ba93e927-64b3-4538-9559-72610a755ed012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
LOTEPREDNOLACTIVE MOIETYZ8CBU6KR16LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
POVIDONESINACTIVE INGREDIENTFZ989GH94ELOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
WATERINACTIVE INGREDIENT059QF0KO0RLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]7
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
LOTEPREDNOL ETABONATEACTIVE MOIETYYEH1EZ96K6LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
POVIDONEINACTIVE INGREDIENTFZ989GH94ELOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32ILOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
TYLOXAPOLINACTIVE INGREDIENTY27PUL9H56LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RLOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-299LOTEMAX (LOTEPREDNOL ETABONATE) SUSPENSION/ DROPS [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 8 package rows20230630_f37d74ac-5f9c-40a8-b43b-35148fc66bbe.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
213263Lotemax 0.5 % Ophthalmic SuspensionPSNf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSNf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
213263loteprednol etabonate 5 MG/ML Ophthalmic Suspension [Lotemax]SBDf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCDf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
213263Lotemax 0.5 % Ophthalmic SuspensionSYf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
213263Lotemax 5 MG/ML Ophthalmic SuspensionSYf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSYf37d74ac-5f9c-40a8-b43b-35148fc66bbe12
213263Lotemax 0.5 % Ophthalmic SuspensionPSNe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSNe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
213263loteprednol etabonate 5 MG/ML Ophthalmic Suspension [Lotemax]SBDe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCDe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
213263Lotemax 0.5 % Ophthalmic SuspensionSYe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
213263Lotemax 5 MG/ML Ophthalmic SuspensionSYe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSYe7ae762f-5e0b-4f64-9323-8f44db2c0b4c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-299-01242080299011 BOTTLE in 1 CARTON (24208-299-01) / 1 mL in 1 BOTTLE1 bottle2020-12-150000-00-00YesNoCurrent
24208-299-05242080299051 BOTTLE in 1 CARTON (24208-299-05) / 5 mL in 1 BOTTLE1 bottle1998-09-030000-00-00NoNoCurrent
24208-299-10242080299101 BOTTLE in 1 CARTON (24208-299-10) / 10 mL in 1 BOTTLE1 bottle1998-09-030000-00-00NoNoCurrent
24208-299-15242080299151 BOTTLE in 1 CARTON (24208-299-15) / 15 mL in 1 BOTTLE1 bottle1998-09-030000-00-00NoNoCurrent