FDA.reportPublic FDA data

LOTEPREDNOL ETABONATE

Product NDC
72603-324
11-digit product format
726030324
Labeler code
72603
Product ID
72603-324_e67f7c52-f550-4d5e-80a8-45b943dead00
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
LOTEPREDNOL ETABONATE
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
NorthStar RxLLC
Application
ANDA212450
Marketing category
ANDA
Marketing start
2024-09-01
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
72603-324-01LOTEPREDNOL ETABONATE5 mL in 1 BOTTLESUSPENSION/ DROPS52
72603-324-01LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
72603-324-02LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
72603-324-02LOTEPREDNOL ETABONATE10 mL in 1 BOTTLESUSPENSION/ DROPS102
72603-324-03LOTEPREDNOL ETABONATE1 in 1 CARTONSUSPENSION/ DROPS12
72603-324-03LOTEPREDNOL ETABONATE15 mL in 1 BOTTLESUSPENSION/ DROPS152

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72603-324-01ML - Milliliter72603-3243803b571-44a2-421c-ae50-296fdaff842b12024-11-05
72603-324-02ML - Milliliter72603-324616cf400-eea1-47d8-87f9-317f585b6f0512024-11-05
72603-324-03ML - Milliliter72603-3243cb9307e-bef4-44c5-ae1f-d33bede9ae0312024-11-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72603-324LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [NORTHSTAR RXLLC]1Current NDC, 6 package rows20240901_ed9f004b-f910-4d75-b205-e96b6254946e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSNed9f004b-f910-4d75-b205-e96b6254946e2
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCDed9f004b-f910-4d75-b205-e96b6254946e2
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSYed9f004b-f910-4d75-b205-e96b6254946e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72603-324-01726030324011 BOTTLE in 1 CARTON (72603-324-01) / 5 mL in 1 BOTTLE1 bottle2024-09-01NoNoHistorical
72603-324-02726030324021 BOTTLE in 1 CARTON (72603-324-02) / 10 mL in 1 BOTTLE1 bottle2024-09-01NoNoHistorical
72603-324-03726030324031 BOTTLE in 1 CARTON (72603-324-03) / 15 mL in 1 BOTTLE1 bottle2024-09-01NoNoHistorical