FDA.reportPublic FDA data

Loteprednol Etabonate

Product NDC
82260-299
11-digit product format
822600299
Labeler code
82260
Product ID
82260-299_316eb8c8-48a7-a4b0-e063-6294a90a0bad
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA020583
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2023-04-07
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
Loteprednol Etabonate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui311382

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
82260-299-05Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS15
82260-299-05Loteprednol Etabonate5 mL in 1 BOTTLESUSPENSION/ DROPS55
82260-299-10Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS15
82260-299-10Loteprednol Etabonate10 mL in 1 BOTTLESUSPENSION/ DROPS105
82260-299-15Loteprednol Etabonate15 mL in 1 BOTTLESUSPENSION/ DROPS155
82260-299-15Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-299-05ML - Milliliter82260-299a0e47567-1376-44ea-9a01-b0d22de980e512024-11-05
82260-299-10ML - Milliliter82260-299c032a97e-f16c-49ff-baa8-043bb5ecb19512025-02-10
82260-299-15ML - Milliliter82260-29929e58ae9-0daa-431a-b4d5-89da154ea2d712025-05-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-299LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [BAUSCH & LOMB AMERICAS INC.]5Current NDC, 6 package rows20250331_f09b1206-97c7-4f21-bda8-94f55128c5cb.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSNf09b1206-97c7-4f21-bda8-94f55128c5cb5
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCDf09b1206-97c7-4f21-bda8-94f55128c5cb5
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSYf09b1206-97c7-4f21-bda8-94f55128c5cb5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82260-299-05822600299051 BOTTLE in 1 CARTON (82260-299-05) / 5 mL in 1 BOTTLE1 bottle2023-04-07NoNoCurrent
82260-299-10822600299101 BOTTLE in 1 CARTON (82260-299-10) / 10 mL in 1 BOTTLE1 bottle2023-04-07NoNoCurrent
82260-299-15822600299151 BOTTLE in 1 CARTON (82260-299-15) / 15 mL in 1 BOTTLE1 bottle2023-04-07NoNoCurrent