FDA.reportPublic FDA data

Lotemax

Product NDC
24208-443
11-digit product format
242080443
Labeler code
24208
Product ID
24208-443_b1d6fda8-73c9-478f-addd-14949e0454e4
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
loteprednol etabonate
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Bausch & Lomb Incorporated
Application
NDA200738
Marketing category
NDA
Marketing start
2011-04-15
Substance
LOTEPREDNOL ETABONATE
Active strength
5 mg/g
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
Lotemax
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6
Rxcui1099500, 1099503

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
24208-443-01Lotemax1.0 g in 1 TUBEOINTMENT1.017
24208-443-01Lotemax1 in 1 CARTONOINTMENT117
24208-443-35Lotemax3.5 g in 1 TUBEOINTMENT3.517
24208-443-35Lotemax1 in 1 CARTONOINTMENT117

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
24208-443-35GM - Gram24208-443093f3f1d-b340-4a4e-b747-462dc00ff0ce12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
LOTEPREDNOL ETABONATEACTIVE INGREDIENTYEH1EZ96K6LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]11
LOTEPREDNOLACTIVE MOIETYZ8CBU6KR16LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]11
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPLOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]11
PETROLATUMINACTIVE INGREDIENT4T6H12BN9ULOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24208-443LOTEMAX (LOTEPREDNOL ETABONATE) OINTMENT [BAUSCH & LOMB INCORPORATED]17Current NDC, Legacy NDC, 4 package rows20230401_902a3c6b-2625-44ec-a077-926e012b3176.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1099503LOTEMAX 0.5 % Ophthalmic OintmentPSN902a3c6b-2625-44ec-a077-926e012b317617
1099500loteprednol etabonate 0.5 % Ophthalmic OintmentPSN902a3c6b-2625-44ec-a077-926e012b317617
1099503loteprednol etabonate 0.005 MG/MG Ophthalmic Ointment [Lotemax]SBD902a3c6b-2625-44ec-a077-926e012b317617
1099500loteprednol etabonate 0.005 MG/MG Ophthalmic OintmentSCD902a3c6b-2625-44ec-a077-926e012b317617
1099503Lotemax 0.005 MG/MG Ophthalmic OintmentSY902a3c6b-2625-44ec-a077-926e012b317617
1099503Lotemax 0.5 % Ophthalmic OintmentSY902a3c6b-2625-44ec-a077-926e012b317617
1099500loteprednol etabonate 0.5 % Ophthalmic OintmentSY902a3c6b-2625-44ec-a077-926e012b317617

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24208-443-01242080443011 TUBE in 1 CARTON (24208-443-01) / 1 g in 1 TUBE1 tube2011-04-150000-00-00YesNoCurrent
24208-443-35242080443351 TUBE in 1 CARTON (24208-443-35) / 3.5 g in 1 TUBE1 tube2011-04-150000-00-00NoNoCurrent