FDA.reportPublic FDA data

Loteprednol Etabonate

Product NDC
72485-665
11-digit product format
724850665
Labeler code
72485
Product ID
72485-665_08a09440-b505-b2c9-e063-6394a90a0d76
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol Etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
ARMAS PHARMACEUTICALS INC.
Application
ANDA207609
Marketing category
ANDA
Marketing start
2023-10-26
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
72485-665-05Loteprednol Etabonate5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS51
72485-665-05Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS11
72485-665-10Loteprednol Etabonate10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS101
72485-665-10Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS11
72485-665-15Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS11
72485-665-15Loteprednol Etabonate15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS151

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72485-665-05ML - Milliliter72485-665f43b706e-a943-4f26-bab4-ac042eeb4b9f12024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72485-665LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [ARMAS PHARMACEUTICALS INC.]1Current NDC, 6 package rows20231102_08a091a8-748f-acc4-e063-6394a90af4bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSN08a091a8-748f-acc4-e063-6394a90af4bc1
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCD08a091a8-748f-acc4-e063-6394a90af4bc1
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSY08a091a8-748f-acc4-e063-6394a90af4bc1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
72485-665-05724850665051 BOTTLE, DROPPER in 1 CARTON (72485-665-05) / 5 mL in 1 BOTTLE, DROPPER2023-10-26NoNoHistorical
72485-665-10724850665101 BOTTLE, DROPPER in 1 CARTON (72485-665-10) / 10 mL in 1 BOTTLE, DROPPER2023-10-26NoNoHistorical
72485-665-15724850665151 BOTTLE, DROPPER in 1 CARTON (72485-665-15) / 15 mL in 1 BOTTLE, DROPPER2023-10-26NoNoHistorical