tobradex

Generic: tobramycin and dexamethasone

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobradex
Generic Name tobramycin and dexamethasone
Labeler novartis pharmaceuticals corporation
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/g, tobramycin 3 mg/g

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0876
Product ID 0078-0876_11f2ad7a-2b97-4316-84b5-49fee866fa81
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050616
Listing Expiration 2026-12-31
Marketing Start 1988-10-15

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 00780876
Hyphenated Format 0078-0876

Supplemental Identifiers

RxCUI
208821 309682
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 (source: ndc)
Generic Name tobramycin and dexamethasone (source: ndc)
Application Number NDA050616 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
  • 3 mg/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE (0078-0876-01)
source: ndc

Packages (1)

0078-0876-01 3.5 g in 1 TUBE (0078-0876-01)

Ingredients (2)

dexamethasone (1 mg/g) tobramycin (3 mg/g)

Linked Drug Pages (1)

TobraDex ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "11f2ad7a-2b97-4316-84b5-49fee866fa81", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["208821", "309682"], "spl_set_id": ["7f310e0e-0d3b-493d-b6c4-238493a2a9b9"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 TUBE (0078-0876-01)", "package_ndc": "0078-0876-01", "marketing_start_date": "20201027"}], "brand_name": "TobraDex", "product_id": "0078-0876_11f2ad7a-2b97-4316-84b5-49fee866fa81", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0078-0876", "generic_name": "tobramycin and dexamethasone", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TobraDex", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/g"}, {"name": "TOBRAMYCIN", "strength": "3 mg/g"}], "application_number": "NDA050616", "marketing_category": "NDA", "marketing_start_date": "19881015", "listing_expiration_date": "20261231"}