Inveltys

Product NDC
0065-9307
11-digit product format
000659307
Labeler code
0065
Product ID
0065-9307_02b53b1c-e4e2-40eb-9283-073996bbee67
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol Etabonate
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
NDA210565
Marketing category
NDA
Marketing start
2026-04-16
Substance
LOTEPREDNOL ETABONATE
Active strength
10 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
Inveltys
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE10 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui2055281, 2055286

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
0065-9307-04Inveltys1 in 1 CARTONSUSPENSION11
0065-9307-04Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.81
0065-9307-05Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.81
0065-9307-05Inveltys1 in 1 CARTONSUSPENSION11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055286INVELTYS 1 % Ophthalmic SuspensionPSNbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 1 % Ophthalmic SuspensionPSNbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286loteprednol etabonate 10 MG/ML Ophthalmic Suspension [Inveltys]SBDbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 10 MG/ML Ophthalmic SuspensionSCDbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286Inveltys 1 % Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055286Inveltys 10 MG/ML Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1
2055281loteprednol etabonate 1 % Ophthalmic SuspensionSYbdd18e84-79b3-4c8b-a07f-eb06cf52e68c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
0065-9307-04000659307041 BOTTLE, DROPPER in 1 CARTON (0065-9307-04) / 2.8 mL in 1 BOTTLE, DROPPER2026-04-16NoNoHistorical
0065-9307-05000659307051 BOTTLE, DROPPER in 1 CARTON (0065-9307-05) / 2.8 mL in 1 BOTTLE, DROPPER2026-04-16YesNoHistorical