tobramycin and dexamethasone

Generic: tobramycin and dexamethasone

Labeler: redpharm drug
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin and dexamethasone
Generic Name tobramycin and dexamethasone
Labeler redpharm drug
Dosage Form SUSPENSION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer
Redpharm Drug

Identifiers & Regulatory

Product NDC 67296-2174
Product ID 67296-2174_44f6e6d5-a53e-e097-e063-6294a90a331a
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 672962174
Hyphenated Format 67296-2174

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 (67296-2174-5)
source: ndc

Packages (1)

67296-2174-5 5 mL in 1 BOTTLE, PLASTIC (67296-2174-5)

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": "44f6e6d5-a53e-e097-e063-6294a90a331a", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["3dd00c21-ae42-0613-e063-6394a90a8012"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Redpharm Drug"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (67296-2174-5)", "package_ndc": "67296-2174-5", "marketing_start_date": "20220317"}], "brand_name": "TOBRAMYCIN AND DEXAMETHASONE", "product_id": "67296-2174_44f6e6d5-a53e-e097-e063-6294a90a331a", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67296-2174", "generic_name": "tobramycin and dexamethasone", "labeler_name": "Redpharm Drug", "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"}