tobramycin

Generic: tobramycin sulfate

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

Drug Facts

Product Profile

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

tobramycin sulfate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-305
Product ID 63323-305_c55fcee9-70c7-4926-bee6-014c0b133249
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065122
Listing Expiration 2026-12-31
Marketing Start 2004-11-30

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323305
Hyphenated Format 63323-305

Supplemental Identifiers

RxCUI
313416 597823
UPC
0363323306052
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 ANDA065122 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-305-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-305-01)
source: ndc

Packages (1)

63323-305-02 25 VIAL, MULTI-DOSE in 1 TRAY (63323-305-02) / 2 mL in 1 VIAL, MULTI-DOSE (63323-305-01)

Ingredients (1)

tobramycin sulfate (10 mg/mL)

Linked Drug Pages (1)

Tobramycin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "c55fcee9-70c7-4926-bee6-014c0b133249", "openfda": {"upc": ["0363323306052"], "unii": ["HJT0RXD7JK"], "rxcui": ["313416", "597823"], "spl_set_id": ["d6dd9460-b030-479a-b3e3-03606e6fcad1"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-305-02)  / 2 mL in 1 VIAL, MULTI-DOSE (63323-305-01)", "package_ndc": "63323-305-02", "marketing_start_date": "20041130"}], "brand_name": "Tobramycin", "product_id": "63323-305_c55fcee9-70c7-4926-bee6-014c0b133249", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-305", "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": "10 mg/mL"}], "application_number": "ANDA065122", "marketing_category": "ANDA", "marketing_start_date": "20041130", "listing_expiration_date": "20261231"}