tobrex

Generic: tobramycin

Labeler: novartis pharmaceuticals corporation
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobrex
Generic Name tobramycin
Labeler novartis pharmaceuticals corporation
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

tobramycin 3 mg/g

Manufacturer
Novartis Pharmaceuticals Corporation

Identifiers & Regulatory

Product NDC 0078-0813
Product ID 0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050555
Listing Expiration 2026-12-31
Marketing Start 1981-06-28

Pharmacologic Class

Established (EPC)
aminoglycoside antibacterial [epc]
Chemical Structure
aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 00780813
Hyphenated Format 0078-0813

Supplemental Identifiers

RxCUI
207850 313414
UNII
VZ8RRZ51VK
NUI
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 tobrex (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number NDA050555 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 3.5 g in 1 TUBE (0078-0813-01)
source: ndc

Packages (1)

0078-0813-01 3.5 g in 1 TUBE (0078-0813-01)

Ingredients (1)

tobramycin (3 mg/g)

Linked Drug Pages (1)

TOBREX ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "5e274c59-a22a-43a1-a3bd-b4f128dbee31", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["207850", "313414"], "spl_set_id": ["5b66bba3-cf97-4a9c-b618-ba5f277f20f6"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Novartis Pharmaceuticals Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "3.5 g in 1 TUBE (0078-0813-01)", "package_ndc": "0078-0813-01", "marketing_start_date": "20220308"}], "brand_name": "TOBREX", "product_id": "0078-0813_5e274c59-a22a-43a1-a3bd-b4f128dbee31", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0078-0813", "generic_name": "tobramycin", "labeler_name": "Novartis Pharmaceuticals Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBREX", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "3 mg/g"}], "application_number": "NDA050555", "marketing_category": "NDA", "marketing_start_date": "19810628", "listing_expiration_date": "20261231"}