tobramycin and dexamethasone

Generic: tobramycin and dexamethasone

Labeler: advanced rx pharmacy of tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

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

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer
Advanced Rx Pharmacy of Tennessee, LLC

Identifiers & Regulatory

Product NDC 80425-0260
Product ID 80425-0260_2a9b792b-f417-e859-e063-6394a90a30e2
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA212715
Listing Expiration 2026-12-31
Marketing Start 2023-02-15

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 804250260
Hyphenated Format 80425-0260

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 ANDA212715 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (80425-0260-1)
source: ndc

Packages (1)

80425-0260-1 5 mL in 1 BOTTLE, PLASTIC (80425-0260-1)

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": "2a9b792b-f417-e859-e063-6394a90a30e2", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["f4c00d9c-3a17-06a0-e053-2a95a90a8413"], "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 Pharmacy of Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (80425-0260-1)", "package_ndc": "80425-0260-1", "marketing_start_date": "20230215"}], "brand_name": "Tobramycin and dexamethasone", "product_id": "80425-0260_2a9b792b-f417-e859-e063-6394a90a30e2", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "80425-0260", "generic_name": "Tobramycin and dexamethasone", "labeler_name": "Advanced Rx Pharmacy 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": "ANDA212715", "marketing_category": "ANDA", "marketing_start_date": "20230215", "listing_expiration_date": "20261231"}