FDA.reportPublic FDA data

Loteprednol Etabonate

Product NDC
50383-265
11-digit product format
503830265
Labeler code
50383
Product ID
50383-265_9e3230b5-521e-4426-bdcd-6fb8c38a197f
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol Etabonate
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Akorn
Application
ANDA207609
Marketing category
ANDA
Marketing start
2019-04-18
Marketing end
0000-00-00
Substance
LOTEPREDNOL ETABONATE
Active strength
5 mg/mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50383-265-052024-01-30C16284748780-11030e365-576b-111a-e063-dadaa90a10e2Loteprednol Etabonate Ophthalmic Suspension, 0.5%
50383-265-102024-01-30C16284748780-11030e365-576b-111a-e063-dadaa90a10e2Loteprednol Etabonate Ophthalmic Suspension, 0.5%
50383-265-152024-01-30C16284748780-11030e365-576b-111a-e063-dadaa90a10e2Loteprednol Etabonate Ophthalmic Suspension, 0.5%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50383-265-05Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS18
50383-265-05Loteprednol Etabonate5 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS58
50383-265-10Loteprednol Etabonate10 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS108
50383-265-10Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS18
50383-265-15Loteprednol Etabonate15 mL in 1 BOTTLE, DROPPERSUSPENSION/ DROPS158
50383-265-15Loteprednol Etabonate1 in 1 CARTONSUSPENSION/ DROPS18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50383-265-05ML - Milliliter50383-265eac7d2e4-def7-4b55-b692-ae441d059fff12019-12-10
50383-265-10ML - Milliliter50383-2658c5ab2b2-5d9b-4ec2-b556-23b9a0d88b3412019-06-19
50383-265-15ML - Milliliter50383-26567ded942-92a6-4608-8d16-46c89fcb42fb12019-06-19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50383-265LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AKORN]8Legacy NDC, 6 package rows20220316_66977c58-1e0c-4add-8ff1-c90050dbcd10.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSN66977c58-1e0c-4add-8ff1-c90050dbcd108
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCD66977c58-1e0c-4add-8ff1-c90050dbcd108
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSY66977c58-1e0c-4add-8ff1-c90050dbcd108

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
50383-265-05503830265051 BOTTLE, DROPPER in 1 CARTON (50383-265-05) > 5 mL in 1 BOTTLE, DROPPER2019-04-180000-00-00NoNoCurrent
50383-265-10503830265101 BOTTLE, DROPPER in 1 CARTON (50383-265-10) > 10 mL in 1 BOTTLE, DROPPER2019-04-180000-00-00NoNoCurrent
50383-265-15503830265151 BOTTLE, DROPPER in 1 CARTON (50383-265-15) > 15 mL in 1 BOTTLE, DROPPER2019-04-180000-00-00NoNoCurrent