tobi

Generic: tobramycin

Labeler: viatris specialty llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobi
Generic Name tobramycin
Labeler viatris specialty llc
Dosage Form SOLUTION
Routes
ORAL RESPIRATORY (INHALATION)
Active Ingredients

tobramycin 300 mg/5mL

Manufacturer
Viatris Specialty LLC

Identifiers & Regulatory

Product NDC 49502-345
Product ID 49502-345_99c630df-5e03-4944-8225-26940d0ae737
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050753
Listing Expiration 2026-12-31
Marketing Start 2022-06-23

Pharmacologic Class

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

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49502345
Hyphenated Format 49502-345

Supplemental Identifiers

RxCUI
213194 348719
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 tobi (source: ndc)
Generic Name tobramycin (source: ndc)
Application Number NDA050753 (source: ndc)
Routes
ORAL RESPIRATORY (INHALATION)
source: ndc

Resolved Composition

Strengths
  • 300 mg/5mL
source: ndc
Packaging
  • 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE
source: ndc

Packages (1)

49502-345-73 56 POUCH in 1 CARTON (49502-345-73) / 4 AMPULE in 1 POUCH (49502-345-99) / 5 mL in 1 AMPULE

Ingredients (1)

tobramycin (300 mg/5mL)

Linked Drug Pages (1)

TOBI ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL", "RESPIRATORY (INHALATION)"], "spl_id": "99c630df-5e03-4944-8225-26940d0ae737", "openfda": {"nui": ["N0000175477", "M0000946"], "unii": ["VZ8RRZ51VK"], "rxcui": ["213194", "348719"], "spl_set_id": ["6a3c3871-1d3a-44d6-8be3-526b30123ef7"], "pharm_class_cs": ["Aminoglycosides [CS]"], "pharm_class_epc": ["Aminoglycoside Antibacterial [EPC]"], "manufacturer_name": ["Viatris Specialty LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "56 POUCH in 1 CARTON (49502-345-73)  / 4 AMPULE in 1 POUCH (49502-345-99)  / 5 mL in 1 AMPULE", "package_ndc": "49502-345-73", "marketing_start_date": "20220623"}], "brand_name": "TOBI", "product_id": "49502-345_99c630df-5e03-4944-8225-26940d0ae737", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "49502-345", "generic_name": "Tobramycin", "labeler_name": "Viatris Specialty LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBI", "active_ingredients": [{"name": "TOBRAMYCIN", "strength": "300 mg/5mL"}], "application_number": "NDA050753", "marketing_category": "NDA", "marketing_start_date": "20220623", "listing_expiration_date": "20261231"}