tobramycin

Generic: tobramycin sulfate

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin sulfate
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, POWDER, FOR SOLUTION
Routes
INTRAVENOUS
Active Ingredients

tobramycin sulfate 1200 mg/30mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-303
Product ID 63323-303_ea244093-d87f-4192-b5c4-59d7b7dbf669
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA050789
Listing Expiration 2026-12-31
Marketing Start 2005-11-23

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323303
Hyphenated Format 63323-303

Supplemental Identifiers

RxCUI
597823
UPC
0363323303013
UNII
HJT0RXD7JK

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 (source: ndc)
Generic Name tobramycin sulfate (source: ndc)
Application Number NDA050789 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 1200 mg/30mL
source: ndc
Packaging
  • 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01)
source: ndc

Packages (1)

63323-303-51 6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01)

Ingredients (1)

tobramycin sulfate (1200 mg/30mL)

Linked Drug Pages (2)

Tobramycin ndc-match (0.9) Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "ea244093-d87f-4192-b5c4-59d7b7dbf669", "openfda": {"upc": ["0363323303013"], "unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["d62ff359-912b-4be1-9fc2-2dde8777eefb"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "6 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (63323-303-51)  / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE (63323-303-01)", "package_ndc": "63323-303-51", "marketing_start_date": "20051123"}], "brand_name": "Tobramycin", "product_id": "63323-303_ea244093-d87f-4192-b5c4-59d7b7dbf669", "dosage_form": "INJECTION, POWDER, FOR SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-303", "generic_name": "TOBRAMYCIN SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "1200 mg/30mL"}], "application_number": "NDA050789", "marketing_category": "NDA", "marketing_start_date": "20051123", "listing_expiration_date": "20261231"}