Inveltys

Product NDC
71571-121
11-digit product format
715710121
Labeler code
71571
Product ID
71571-121_753138b5-b236-414d-bc64-d33b52d8224f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION
Route
TOPICAL
Labeler
ALCON LABORATORIES, INC.
Application
NDA210565
Marketing category
NDA
Marketing start
2018-08-22
Substance
LOTEPREDNOL ETABONATE
Active strength
10 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
Inveltys
Listing expiration
2026-12-31

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
71571-121-20Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.810
71571-121-28Inveltys1 in 1 CARTONSUSPENSION110
71571-121-28Inveltys2.8 mL in 1 BOTTLE, DROPPERSUSPENSION2.810

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71571-121-28ML - Milliliter71571-12123ea90ab-6ed1-4ecf-b836-e1728454040012018-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71571-121INVELTYS (LOTEPREDNOL ETABONATE) SUSPENSION [ALCON LABORATORIES, INC.]10Current NDC, Legacy NDC, 3 package rows20240402_2ec16df8-2e5c-4e06-8d28-21df76f27d72.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2055286INVELTYS 1 % Ophthalmic SuspensionPSN2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055281loteprednol etabonate 1 % Ophthalmic SuspensionPSN2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055286loteprednol etabonate 10 MG/ML Ophthalmic Suspension [Inveltys]SBD2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055281loteprednol etabonate 10 MG/ML Ophthalmic SuspensionSCD2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055286Inveltys 1 % Ophthalmic SuspensionSY2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055286Inveltys 10 MG/ML Ophthalmic SuspensionSY2ec16df8-2e5c-4e06-8d28-21df76f27d7210
2055281loteprednol etabonate 1 % Ophthalmic SuspensionSY2ec16df8-2e5c-4e06-8d28-21df76f27d7210

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71571-121-20715710121202.8 mL in 1 BOTTLE, DROPPER (71571-121-20) 2.8 ml2018-08-220000-00-00YesNoCurrent
71571-121-28715710121281 BOTTLE, DROPPER in 1 CARTON (71571-121-28) / 2.8 mL in 1 BOTTLE, DROPPER2018-08-220000-00-00NoNoCurrent