tobradex st

Generic: tobramycin / dexamethasone

Labeler: harrow eye, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobradex st
Generic Name tobramycin / dexamethasone
Labeler harrow eye, llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dexamethasone .5 mg/mL, tobramycin 3 mg/mL

Manufacturer
Harrow Eye, LLC

Identifiers & Regulatory

Product NDC 82667-011
Product ID 82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050818
Listing Expiration 2026-12-31
Marketing Start 2025-03-31

Pharmacologic Class

Established (EPC)
corticosteroid [epc] aminoglycoside antibacterial [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 82667011
Hyphenated Format 82667-011

Supplemental Identifiers

RxCUI
849115 1011080
UNII
7S5I7G3JQL VZ8RRZ51VK
NUI
N0000175576 N0000175450 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 tobradex st (source: ndc)
Generic Name tobramycin / dexamethasone (source: ndc)
Application Number NDA050818 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .5 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER
  • 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (2)

82667-011-00 1 BOTTLE, DROPPER in 1 CARTON (82667-011-00) / 1 mL in 1 BOTTLE, DROPPER 82667-011-05 1 BOTTLE, DROPPER in 1 CARTON (82667-011-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (2)

dexamethasone (.5 mg/mL) tobramycin (3 mg/mL)

Linked Drug Pages (1)

Tobradex ST ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "31ba978f-7bc8-031f-e063-6394a90ae09c", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["849115", "1011080"], "spl_set_id": ["3b99dbb3-ac84-4d0d-b30f-a5db44fdc316"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Harrow Eye, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82667-011-00)  / 1 mL in 1 BOTTLE, DROPPER", "package_ndc": "82667-011-00", "marketing_start_date": "20250331"}, {"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (82667-011-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "82667-011-05", "marketing_start_date": "20250331"}], "brand_name": "Tobradex ST", "product_id": "82667-011_31ba978f-7bc8-031f-e063-6394a90ae09c", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "82667-011", "generic_name": "tobramycin / dexamethasone", "labeler_name": "Harrow Eye, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobradex ST", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": ".5 mg/mL"}, {"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "NDA050818", "marketing_category": "NDA", "marketing_start_date": "20250331", "listing_expiration_date": "20261231"}