FDA.reportPublic FDA data

loteprednol etabonate

Product NDC
70748-300
11-digit product format
707480300
Labeler code
70748
Product ID
70748-300_822adc09-88c3-41fa-922a-66dfa7e412b2
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
SUSPENSION
Route
OPHTHALMIC
Labeler
Lupin Pharmaceuticals, Inc.
Application
ANDA215719
Marketing category
ANDA
Marketing start
2025-07-15
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
70748-300-01loteprednol etabonate5 mL in 1 BOTTLESUSPENSION53
70748-300-01loteprednol etabonate1 in 1 CARTONSUSPENSION13
70748-300-02loteprednol etabonate10 mL in 1 BOTTLESUSPENSION103
70748-300-02loteprednol etabonate1 in 1 CARTONSUSPENSION13
70748-300-03loteprednol etabonate1 in 1 CARTONSUSPENSION13
70748-300-03loteprednol etabonate15 mL in 1 BOTTLESUSPENSION153

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70748-300-01ML - Milliliter70748-30097ed24a9-98fe-4cbb-8959-1d53f8837c9f12025-08-11
70748-300-02ML - Milliliter70748-300b9173ff9-3ada-4551-8bf0-5b38835942e912025-08-11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionPSN1a506712-b032-463a-9a17-4805584458083
311382loteprednol etabonate 5 MG/ML Ophthalmic SuspensionSCD1a506712-b032-463a-9a17-4805584458083
311382loteprednol etabonate 0.5 % Ophthalmic SuspensionSY1a506712-b032-463a-9a17-4805584458083

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
70748-300-01707480300011 BOTTLE in 1 CARTON (70748-300-01) / 5 mL in 1 BOTTLE1 bottle2025-07-15NoNoHistorical
70748-300-02707480300021 BOTTLE in 1 CARTON (70748-300-02) / 10 mL in 1 BOTTLE1 bottle2025-08-27NoNoHistorical
70748-300-03707480300031 in 1 CARTONHistorical