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 multiple dose vials, is supplied as follows: Product Code Unit of Sale Strength Each 300502 NDC 63323-305-02 Unit of 25 20 mg per 2 mL (10 mg per mL) 2 mL fill, in a 2 mL vial. NDC 63323-305-01 2 mL Multiple Dose Vial 300602 NDC 63323-306-02 Unit of 25 80 mg per 2 mL (40 mg per mL) 2 mL fill, in a 2 mL vial. NDC 63323-306-01 2 mL Multiple Dose Vial 300630 NDC 63323-306-30 Unit of 10 1,200 mg per 30 mL (40 mg per mL) 30 mL fill, in a 30 mL vial. NDC 63323-306-05 30 mL Multiple Dose Vial 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. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45963K Revised: December 2023 Fresenius Kabi Logo
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 2 mL Multiple Dose Vial Label NDC 63323-305-01 300502 Tobramycin Injection, USP PEDIATRIC 20 mg per 2 mL (10 mg per mL) For IM or IV use. MUST BE DILUTED BEFORE IV USE . 2 mL Multiple Dose Vial Rx only vial
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 2 mL Multiple Dose Vial Tray Label NDC 63323-305-02 300502 Tobramycin Injection, USP PEDIATRIC 20 mg per 2 mL (10 mg per mL) For IM or IV use. MUST BE DILUTED BEFORE IV USE . 25 x 2 mL Multiple Dose Vials Rx only tray
  • PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 30 mL Multiple Dose Vial Label NDC 63323-306-05 300630 Tobramycin Injection, USP 1,200 mg per 30 mL (40 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. 30 mL Multiple Dose Vial Rx only 1200
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Tobramycin 2 mL Multiple Dose Vial Label NDC 63323-306-01 300602 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 Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Tobramycin 2 mL Multiple Dose Tray Label NDC 63323-306-02 300602 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 PACKAGE LABEL – PRINCIPAL DISPLAY – Tobramycin 2 mL Multiple Dose Tray Label
  • PACKAGE LABEL – PRINCIPAL DISPLAY – Tobramycin 30 mL Multiple Dose Tray Label NDC 63323-306-30 300630 Tobramycin Injection, USP 1,200 mg per 30 mL (40 mg per mL) For intramuscular or intravenous use. MUST BE DILUTED BEFORE INTRAVENOUS USE. 10 x 30 mL Multiple Dose Vials Rx only PACKAGE LABEL – PRINCIPAL DISPLAY – Tobramycin 30 mL Multiple Dose Tray Label
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"}