FDA.reportPublic FDA data

Loteprednol Etabonate

Product NDC
70244-034
11-digit product format
702440034
Labeler code
70244
Product ID
70244-034_4faa8338-1297-3876-e063-6294a90a42fa
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol Etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Sentiss Pharmaceuticals LLC
Application
ANDA207609
Marketing category
ANDA
Marketing start
2026-04-17
Substance
LOTEPREDNOL ETABONATE
Active strength
5 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 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
70244-034-01Loteprednol Etabonate5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS52
70244-034-01Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS12
70244-034-02Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS12
70244-034-02Loteprednol Etabonate10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS102
70244-034-03Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS12
70244-034-03Loteprednol Etabonate15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS152

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSN4faa8cbe-2004-e8b5-e063-6394a90a35502
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCD4faa8cbe-2004-e8b5-e063-6394a90a35502
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSY4faa8cbe-2004-e8b5-e063-6394a90a35502

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
70244-034-01702440034011 BOTTLE, DROPPER in 1 CARTON (70244-034-01) / 5 mL in 1 BOTTLE, DROPPER2026-04-17NoNoCurrent
70244-034-02702440034021 BOTTLE, DROPPER in 1 CARTON (70244-034-02) / 10 mL in 1 BOTTLE, DROPPER2026-04-17NoNoCurrent
70244-034-03702440034031 BOTTLE, DROPPER in 1 CARTON (70244-034-03) / 15 mL in 1 BOTTLE, DROPPER2026-04-17NoNoCurrent