loteprednol etabonate and tobramycin

Generic: loteprednol etabonate and tobramycin

Labeler: bausch & lomb americas inc.
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name loteprednol etabonate and tobramycin
Generic Name loteprednol etabonate and tobramycin
Labeler bausch & lomb americas inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

loteprednol etabonate 5 mg/mL, tobramycin 3 mg/mL

Manufacturer
Bausch & Lomb Americas Inc.

Identifiers & Regulatory

Product NDC 82260-358
Product ID 82260-358_48d4400d-e246-f109-e063-6394a90a8103
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050804
Listing Expiration 2027-12-31
Marketing Start 2026-01-09

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82260358
Hyphenated Format 82260-358

Supplemental Identifiers

RxCUI
545255
UNII
YEH1EZ96K6 VZ8RRZ51VK
NUI
N0000175477 M0000946

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name loteprednol etabonate and tobramycin (source: ndc)
Generic Name loteprednol etabonate and tobramycin (source: ndc)
Application Number NDA050804 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 5 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82260-358-10) / 10 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82260-358-05 1 BOTTLE, DROPPER in 1 CARTON (82260-358-05) / 5 mL in 1 BOTTLE, DROPPER 82260-358-10 1 BOTTLE, DROPPER in 1 CARTON (82260-358-10) / 10 mL in 1 BOTTLE, DROPPER

Ingredients (2)

loteprednol etabonate (5 mg/mL) tobramycin (3 mg/mL)

Linked Drug Pages (1)

Loteprednol etabonate and tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "48d4400d-e246-f109-e063-6394a90a8103", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["YEH1EZ96K6", "VZ8RRZ51VK"], "rxcui": ["545255"], "spl_set_id": ["75df79e9-f064-4f46-9837-8d4d536517a3"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Bausch & Lomb Americas Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-358-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-358-05", "marketing_start_date": "20260109"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82260-358-10)  / 10 mL in 1 BOTTLE, DROPPER", "package_ndc": "82260-358-10", "marketing_start_date": "20260109"}], "brand_name": "Loteprednol etabonate and tobramycin", "product_id": "82260-358_48d4400d-e246-f109-e063-6394a90a8103", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82260-358", "generic_name": "loteprednol etabonate and tobramycin", "labeler_name": "Bausch & Lomb Americas Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Loteprednol etabonate and tobramycin", "active_ingredients": [{"name": "LOTEPREDNOL ETABONATE", "strength": "5 mg/mL"}, {"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "NDA050804", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20260109", "listing_expiration_date": "20271231"}