LOTEMAX

Product NDC
24208-503
11-digit product format
242080503
Labeler code
24208
Product ID
24208-503_253b0a9d-16fe-2eb1-e063-6294a90ac5e0
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA202872
Marketing category
NDA
Marketing start
2012-10-12
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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui1312625, 1312627

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
24208-503-07LOTEMAX5 g in 1 BOTTLEGEL512
24208-503-07LOTEMAX1 in 1 CARTONGEL112
24208-503-48LOTEMAX1 in 1 CARTONGEL112
24208-503-48LOTEMAX0.5 g in 1 BOTTLEGEL0.512
24208-503-96LOTEMAX5 g in 1 BOTTLEGEL512
24208-503-96LOTEMAX1 in 1 CARTONGEL112

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-503LOTEMAX (LOTEPREDNOL ETABONATE) GEL [BAUSCH & LOMB INCORPORATED]12Current NDC, Legacy NDC, 6 package rows20241027_9a666065-d467-42b8-8ecd-0ec1de9986d5.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1312627LOTEMAX 0.5 % Ophthalmic GelPSN9a666065-d467-42b8-8ecd-0ec1de9986d512
1312625loteprednol etabonate 0.5 % Ophthalmic GelPSN9a666065-d467-42b8-8ecd-0ec1de9986d512
1312627loteprednol etabonate 0.005 MG/MG Ophthalmic Gel [Lotemax]SBD9a666065-d467-42b8-8ecd-0ec1de9986d512
1312625loteprednol etabonate 0.005 MG/MG Ophthalmic GelSCD9a666065-d467-42b8-8ecd-0ec1de9986d512
1312627Lotemax 0.005 MG/MG Ophthalmic GelSY9a666065-d467-42b8-8ecd-0ec1de9986d512
1312627Lotemax 0.5 % Ophthalmic GelSY9a666065-d467-42b8-8ecd-0ec1de9986d512
1312625loteprednol etabonate 0.5 % Ophthalmic GelSY9a666065-d467-42b8-8ecd-0ec1de9986d512

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-503-07242080503071 BOTTLE in 1 CARTON (24208-503-07) / 5 g in 1 BOTTLE1 bottle2012-10-120000-00-00NoNoCurrent
24208-503-48242080503481 BOTTLE in 1 CARTON (24208-503-48) / .5 g in 1 BOTTLE1 bottle2012-10-120000-00-00YesNoCurrent
24208-503-96242080503961 BOTTLE in 1 CARTON (24208-503-96) / 5 g in 1 BOTTLE1 bottle2012-10-120000-00-00YesNoCurrent