tobramycin and dexamethasone

Generic: tobramycin and dexamethasone

Labeler: a-s medication solutions
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 a-s medication solutions
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-1135
Product ID 50090-1135_3ae18ae8-7fe7-4f51-86d5-25d847181f3f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA AUTHORIZED GENERIC
Application Number NDA050592
Listing Expiration 2026-12-31
Marketing Start 2009-01-02

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 500901135
Hyphenated Format 50090-1135

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
  • 2.5 mL in 1 BOTTLE (50090-1135-0)
source: ndc

Packages (1)

50090-1135-0 2.5 mL in 1 BOTTLE (50090-1135-0)

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": "3ae18ae8-7fe7-4f51-86d5-25d847181f3f", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["e4ddce2f-1b91-46e1-a8f0-a38394d4e672"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "2.5 mL in 1 BOTTLE (50090-1135-0)", "package_ndc": "50090-1135-0", "marketing_start_date": "20141128"}], "brand_name": "Tobramycin and Dexamethasone", "product_id": "50090-1135_3ae18ae8-7fe7-4f51-86d5-25d847181f3f", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "50090-1135", "generic_name": "Tobramycin and Dexamethasone", "labeler_name": "A-S Medication Solutions", "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": "20090102", "listing_expiration_date": "20261231"}