tobramycin and dexamethasone

Generic: tobramycin and dexamethasone

Labeler: nucare pharmaceuticals,inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin and dexamethasone
Generic Name tobramycin and dexamethasone
Labeler nucare pharmaceuticals,inc.
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4203
Product ID 68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064134
Listing Expiration 2026-12-31
Marketing Start 1999-10-27

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 680714203
Hyphenated Format 68071-4203

Supplemental Identifiers

RxCUI
309683
UPC
0368071420357
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 ANDA064134 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 1 mg/mL
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOX (68071-4203-5)
source: ndc

Packages (1)

68071-4203-5 5 mL in 1 BOX (68071-4203-5)

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": "1a3b96b0-10ad-9bb1-e063-6294a90ab279", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "upc": ["0368071420357"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["61693e79-81d1-3162-e053-2a91aa0ae925"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOX (68071-4203-5)", "package_ndc": "68071-4203-5", "marketing_start_date": "20171228"}], "brand_name": "Tobramycin and Dexamethasone", "product_id": "68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68071-4203", "generic_name": "Tobramycin and Dexamethasone", "labeler_name": "NuCare Pharmaceuticals,Inc.", "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": "ANDA064134", "marketing_category": "ANDA", "marketing_start_date": "19991027", "listing_expiration_date": "20261231"}