FDA.reportPublic FDA data

loteprednol etabonate

Product NDC
82260-361
11-digit product format
822600361
Labeler code
82260
Product ID
82260-361_4a467df9-02df-061f-e063-6294a90a3beb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Bausch & Lomb Americas Inc.
Application
NDA020803
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2024-02-09
Substance
LOTEPREDNOL ETABONATE
Active strength
2 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
loteprednol etabonate
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE2 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui311381

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
82260-361-05loteprednol etabonate5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS54
82260-361-05loteprednol etabonate1 in 1 CARTONSUSPENSION/ DROPS14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82260-361-05ML - Milliliter82260-3612c68ca04-5319-45b0-bc83-539c26c7983112024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82260-361LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [BAUSCH & LOMB AMERICAS INC.]3Current NDC, 2 package rows20250206_7714824b-29ed-442a-ad2d-13ee2fc6bc42.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionPSN7714824b-29ed-442a-ad2d-13ee2fc6bc424
311381loteprednol etabonate 2 MG/ML Ophthalmic SuspensionSCD7714824b-29ed-442a-ad2d-13ee2fc6bc424
311381loteprednol etabonate 0.2 % Ophthalmic SuspensionSY7714824b-29ed-442a-ad2d-13ee2fc6bc424

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
82260-361-05822600361051 BOTTLE, DROPPER in 1 CARTON (82260-361-05) / 5 mL in 1 BOTTLE, DROPPER2024-02-09NoNoCurrent