tobramycin and dexamethasone (0574-4031)

Drug Facts

Product Profile

Brand Name tobramycin and dexamethasone

Generic Name tobramycin and dexamethasone

Labeler padagis us llc

Dosage Form SUSPENSION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer

Padagis US LLC

Identifiers & Regulatory

Product NDC 0574-4031

Product ID 0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA212715

Listing Expiration 2026-12-31

Marketing Start 2022-03-17

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 05744031

Hyphenated Format 0574-4031

Supplemental Identifiers

RxCUI

309683

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 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 (0574-4031-05)
10 mL in 1 BOTTLE, PLASTIC (0574-4031-10)
2.5 mL in 1 BOTTLE, PLASTIC (0574-4031-25)

source: ndc

Packages (3)

0574-4031-05 5 mL in 1 BOTTLE, PLASTIC (0574-4031-05) 0574-4031-10 10 mL in 1 BOTTLE, PLASTIC (0574-4031-10) 0574-4031-25 2.5 mL in 1 BOTTLE, PLASTIC (0574-4031-25)

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": "7c012e78-01c6-4b9a-a971-62a64fe6885a", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["7e34b1a9-8d21-41db-9070-37227975414f"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Padagis US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (0574-4031-05)", "package_ndc": "0574-4031-05", "marketing_start_date": "20220317"}, {"sample": false, "description": "10 mL in 1 BOTTLE, PLASTIC (0574-4031-10)", "package_ndc": "0574-4031-10", "marketing_start_date": "20220317"}, {"sample": false, "description": "2.5 mL in 1 BOTTLE, PLASTIC (0574-4031-25)", "package_ndc": "0574-4031-25", "marketing_start_date": "20220317"}], "brand_name": "TOBRAMYCIN AND DEXAMETHASONE", "product_id": "0574-4031_7c012e78-01c6-4b9a-a971-62a64fe6885a", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "0574-4031", "generic_name": "tobramycin and dexamethasone", "labeler_name": "Padagis US 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": "20220317", "listing_expiration_date": "20261231"}