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 40 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-306
Product ID 63323-306_50d13410-0de5-4548-85a3-e38240621c4c
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065122
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 63323306
Hyphenated Format 63323-306

Supplemental Identifiers

RxCUI
597823
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
  • 40 mg/mL
source: ndc
Packaging
  • HOW SUPPLIED: Tobramycin Injection, USP, in a multiple dose vial, is supplied as follows: Product No. NDC No. Strength PRX300602 63323-306-26 80 mg per 2 mL (40 mg per mL) 2 mL in a 2 mL vial, packaged in 25. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. The container closure is not made with natural rubber latex.
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 2 mL Multiple Dose Vial Label Tobramycin Injection, USP 80 mg per 2 mL (40 mg per mL) For IM or IV use. MUST BE DILUTED BEFORE IV USE . Usual dosage: See package insert. 2 mL Multiple Dose Vial Rx only PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 2 mL Multiple Dose Vial Tray Label Tobramycin Injection, USP 80 mg per 2 mL (40 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE IV USE . 25 x 2 mL Multiple Dose Vials Rx only vial tray
source: label

Packages (0)

No package records.

Ingredients (1)

tobramycin sulfate (40 mg/mL)

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": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "50d13410-0de5-4548-85a3-e38240621c4c", "openfda": {"unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["0b4a4b00-7f78-4e95-b870-f88fea73348e"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Tobramycin", "product_id": "63323-306_50d13410-0de5-4548-85a3-e38240621c4c", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-306", "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": "40 mg/mL"}], "application_number": "ANDA065122", "marketing_category": "ANDA", "marketing_start_date": "20051123", "listing_expiration_date": "20261231"}