FDA.reportPublic FDA data

Loteprednol etabonate and Tobramycin

Product NDC
46708-801
11-digit product format
467080801
Labeler code
46708
Product ID
46708-801_a6d68829-f7b6-4b9b-ad44-110c47609918
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Loteprednol etabonate and Tobramycin
Dosage form
SUSPENSION/ DROPS
Route
OPHTHALMIC
Labeler
Alembic Pharmaceuticals Limited
Application
ANDA217597
Marketing category
ANDA
Marketing start
2025-12-10
Substance
LOTEPREDNOL ETABONATE; TOBRAMYCIN
Active strength
5; 3 mg/mL; mg/mL
Pharmacologic classes
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], 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
Loteprednol etabonate and Tobramycin
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LOTEPREDNOL ETABONATE5 mg/mL
TOBRAMYCIN3 mg/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiYEH1EZ96K6, VZ8RRZ51VK
Rxcui545255

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
f297c7c1-845a-4369-8c02-c51b92d6ae8eProduct name320240725
551d952d-4ce2-24f0-9ab0-630ad9aae596Product name220231211
941f67d9-7f03-56d2-750c-36de24f654dbProduct name320221117
9cfa145f-dbe9-bc02-83c2-692786ef6676Product name920210928
2f9713b8-5e7e-bbcc-b364-1b2c27a63796Product name420210903
32a533bc-01c7-2b9f-bbf7-ecfb0d964277Product name420210625
4300453c-d545-46d1-b115-18b12b4ccf79Product name120210525
3f316f1c-2561-47c9-9865-ba2be69e0b3eProduct name120190614
f1ee2aaf-88da-4841-948b-7d3a6af14e35Product name120181206
9f5124fb-08b0-4c3e-8e12-a1a6ff310cbaProduct name120150309
745a62af-e1c0-4ca3-6d6e-2b6455b903beProduct name120140508
9ea85abb-fa68-5da6-ab60-2c7eef579000Product name120140508
aa1cd319-ece7-51f7-3a9d-52a64f5f4e81Product name120140508
b5c5cd73-a27b-5e41-bd36-3de9471473cdProduct name120140508
d029211e-5e6b-725f-3696-ac6ff77da222Product name120140508
ef5b7aed-2b01-3ba8-5a1c-3bc9c9f03bb1Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46708-801-05Loteprednol etabonate and Tobramycin1 in 1 CARTONSUSPENSION/ DROPS11
46708-801-05Loteprednol etabonate and Tobramycin5 mL in 1 BOTTLESUSPENSION/ DROPS51
46708-801-10Loteprednol etabonate and Tobramycin1 in 1 CARTONSUSPENSION/ DROPS11
46708-801-10Loteprednol etabonate and Tobramycin10 mL in 1 BOTTLESUSPENSION/ DROPS101

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
545255loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic SuspensionPSNa6d68829-f7b6-4b9b-ad44-110c476099181
545255loteprednol etabonate 5 MG/ML / tobramycin 3 MG/ML Ophthalmic SuspensionSCDa6d68829-f7b6-4b9b-ad44-110c476099181
545255loteprednol etabonate 0.5 % / tobramycin 0.3 % Ophthalmic SuspensionSYa6d68829-f7b6-4b9b-ad44-110c476099181

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
46708-801-05467080801051 BOTTLE in 1 CARTON (46708-801-05) / 5 mL in 1 BOTTLE1 bottle2025-12-10NoNoHistorical
46708-801-10467080801101 BOTTLE in 1 CARTON (46708-801-10) / 10 mL in 1 BOTTLE1 bottle2025-12-10NoNoHistorical