tobramycin and dexamethasone (61314-647)

Drug Facts

Product Profile

Brand Name tobramycin and dexamethasone

Generic Name tobramycin and dexamethasone

Labeler sandoz inc

Dosage Form SUSPENSION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

dexamethasone 1 mg/mL, tobramycin 3 mg/mL

Manufacturer

Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-647

Product ID 61314-647_e7d4aa10-eff7-4523-9fa2-a60e19e8dee2

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 61314647

Hyphenated Format 61314-647

Supplemental Identifiers

RxCUI

309683

UPC

0361314647252

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 NDA050592 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

1 mg/mL
3 mg/mL

source: ndc

Packaging

1 BOTTLE in 1 CARTON (61314-647-05) / 5 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (61314-647-10) / 10 mL in 1 BOTTLE
1 BOTTLE in 1 CARTON (61314-647-25) / 2.5 mL in 1 BOTTLE

source: ndc

Packages (3)

61314-647-05 1 BOTTLE in 1 CARTON (61314-647-05) / 5 mL in 1 BOTTLE 61314-647-10 1 BOTTLE in 1 CARTON (61314-647-10) / 10 mL in 1 BOTTLE 61314-647-25 1 BOTTLE in 1 CARTON (61314-647-25) / 2.5 mL in 1 BOTTLE

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": "e7d4aa10-eff7-4523-9fa2-a60e19e8dee2", "openfda": {"nui": ["N0000175576", "N0000175450", "N0000175477", "M0000946"], "upc": ["0361314647252"], "unii": ["7S5I7G3JQL", "VZ8RRZ51VK"], "rxcui": ["309683"], "spl_set_id": ["05fd0c36-39b4-4a43-8490-eb8dfc0920ae"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Corticosteroid [EPC]", "Aminoglycoside Antibacterial [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-647-05)  / 5 mL in 1 BOTTLE", "package_ndc": "61314-647-05", "marketing_start_date": "20150102"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-647-10)  / 10 mL in 1 BOTTLE", "package_ndc": "61314-647-10", "marketing_start_date": "20090102"}, {"sample": false, "description": "1 BOTTLE in 1 CARTON (61314-647-25)  / 2.5 mL in 1 BOTTLE", "package_ndc": "61314-647-25", "marketing_start_date": "20090102"}], "brand_name": "Tobramycin and Dexamethasone", "product_id": "61314-647_e7d4aa10-eff7-4523-9fa2-a60e19e8dee2", "dosage_form": "SUSPENSION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]", "Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "61314-647", "generic_name": "Tobramycin and Dexamethasone", "labeler_name": "Sandoz 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": "NDA050592", "marketing_category": "NDA AUTHORIZED GENERIC", "marketing_start_date": "20090102", "listing_expiration_date": "20261231"}