tobramycin and dexamethasone

Generic: tobramycin and dexamethasone

Labeler: advanced rx of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA AUTHORIZED GENERIC Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin and dexamethasone
Generic Name tobramycin and dexamethasone
Labeler advanced rx of tennessee, llc
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer
Advanced Rx of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0366
Product ID 80425-0366_2a998d83-7bae-3f5e-e063-6294a90acd3d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050592
Listing Expiration 2026-12-31
Marketing Start 2023-11-02

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 804250366
Hyphenated Format 80425-0366

Supplemental Identifiers

RxCUI
309683
UNII
7S5I7G3JQL VZ8RRZ51VK
NUI
N0000175576 N0000175450 N0000175477 M0000946

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 tobramycin and dexamethasone (source: ndc)
Generic Name tobramycin and dexamethasone (source: ndc)
Application Number NDA050592 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE (80425-0366-1)
source: ndc

Packages (1)

80425-0366-1 5 mL in 1 BOTTLE (80425-0366-1)

Ingredients (2)

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

Linked Drug Pages (1)

Tobramycin and Dexamethasone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2a998d83-7bae-3f5e-e063-6294a90acd3d", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["09315f0b-f15a-30d5-e063-6394a90ac8dd"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Advanced Rx of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (80425-0366-1)", "package_ndc": "80425-0366-1", "marketing_start_date": "20231102"}], "brand_name": "Tobramycin and Dexamethasone", "product_id": "80425-0366_2a998d83-7bae-3f5e-e063-6294a90acd3d", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0366", "generic_name": "Tobramycin and Dexamethasone", "labeler_name": "Advanced Rx of Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin and Dexamethasone", "active_ingredients": [{"name": "DEXAMETHASONE", "strength": "1 mg/mL"}, {"name": "TOBRAMYCIN", "strength": "3 mg/mL"}], "application_number": "NDA050592", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20231102", "listing_expiration_date": "20261231"}