Lotemax SM

Product NDC
24208-507
11-digit product format
242080507
Labeler code
24208
Product ID
24208-507_4e5af379-3e45-420f-e063-6294a90a4ada
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA208219
Marketing category
NDA
Marketing start
2019-02-25
Substance
LOTEPREDNOL ETABONATE
Active strength
3.8 mg/g
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
Lotemax SM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE3.8 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui2118537, 2118539

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
24208-507-01Lotemax SM1 in 1 CARTONGEL15
24208-507-01Lotemax SM0.5 g in 1 BOTTLEGEL0.55
24208-507-02Lotemax SM1 in 1 CARTONGEL15
24208-507-02Lotemax SM5 g in 1 BOTTLEGEL55
24208-507-07Lotemax SM1 in 1 CARTONGEL15
24208-507-07Lotemax SM5 g in 1 BOTTLEGEL55

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-507-07GM - Gram24208-5078a9e5827-eccb-4f83-849b-3eb34dff958712019-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-507LOTEMAX SM (LOTEPREDNOL ETABONATE) GEL [BAUSCH & LOMB INCORPORATED]4Current NDC, Legacy NDC, 6 package rows20230531_6f9477b5-699f-4d3b-b9a6-0cc238266237.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2118539LOTEMAX SM 0.38 % Ophthalmic GelPSN6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118537loteprednol etabonate 0.38 % Ophthalmic GelPSN6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118539loteprednol etabonate 0.0038 MG/MG Ophthalmic Gel [Lotemax]SBD6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118537loteprednol etabonate 0.0038 MG/MG Ophthalmic GelSCD6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118539Lotemax 0.0038 MG/MG Ophthalmic GelSY6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118539Lotemax 0.38 % Ophthalmic GelSY6f9477b5-699f-4d3b-b9a6-0cc2382662375
2118537loteprednol etabonate 0.38 % Ophthalmic GelSY6f9477b5-699f-4d3b-b9a6-0cc2382662375

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-507-01242080507011 BOTTLE in 1 CARTON (24208-507-01) / .5 g in 1 BOTTLE1 bottle2019-02-250000-00-00YesNoCurrent
24208-507-02242080507021 BOTTLE in 1 CARTON (24208-507-02) > 5 g in 1 BOTTLE1 bottle2019-02-250000-00-00YesNoCurrent
24208-507-07242080507071 BOTTLE in 1 CARTON (24208-507-07) / 5 g in 1 BOTTLE1 bottle2019-02-250000-00-00NoNoCurrent