tobramycin
Generic: tobramycin sulfate
Labeler: fresenius kabi usa, llcDrug Facts
Product Profile
Brand Name
tobramycin
Generic Name
tobramycin sulfate
Labeler
fresenius kabi usa, llc
Dosage Form
INJECTION, SOLUTION
Routes
Active Ingredients
tobramycin sulfate 40 mg/mL
Manufacturer
Identifiers & Regulatory
Product NDC
63323-307
Product ID
63323-307_69344ccc-5426-4a9d-9458-1e54f005518f
Product Type
HUMAN PRESCRIPTION DRUG
Marketing Category
ANDA
Application Number
ANDA065120
Listing Expiration
2026-12-31
Marketing Start
2004-11-30
Pharmacologic Class
Classes
Normalized Code Variants
Searchable formats for this product NDC code
Digits Only
63323307
Hyphenated Format
63323-307
Supplemental Identifiers
RxCUI
UPC
UNII
Packaging Origin
Original Packager
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
ANDA065120 (source: ndc)
Routes
source: ndc
Resolved Composition
Strengths
- 40 mg/mL
Packaging
- HOW SUPPLIED: Tobramycin Injection USP, in the Pharmacy Bulk Package, is supplied as follows: Product Code Unit of Sale Strength Each 300751 NDC 63323-307-51 2 g per 50 mL (40 mg per mL) 50 mL fill, in a 60 mL vial 60 mL Pharmacy Bulk Package vial, packaged individually 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. Tobramycin Injection, USP, is also available in multiple dose vials: 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 Lake Zurich, IL 60047 www.fresenius-kabi.com/us 45964H Revised: October 2023 tobra-img-01.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 50 mL Vial Label NDC 63323-307-51 300751 TOBRAMYCIN INJECTION, USP 2 g per 50 mL (40 mg per mL) PHARMACY BULK PACKAGE - Not For Direct Infusion For Intravenous Use* Rx only *MUST BE DILUTED BEFORE IV USE. THIS PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT. tobra-label-01.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY - Tobramycin 50 mL Vial Carton Panel NDC 63323-307-51 300751 TOBRAMYCIN INJECTION, USP 2 g per 50 mL (40 mg per mL) PHARMACY BULK PACKAGE Not For Direct Infusion For Intravenous Use* *MUST BE DILUTED BEFORE IV USE. THIS PACKAGE IS NOT INTENDED TO BE DISPENSED AS A UNIT. Rx only tobra-label-02.jpg
Packages (0)
No package records.
Ingredients (1)
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["INTRAVENOUS"], "spl_id": "69344ccc-5426-4a9d-9458-1e54f005518f", "openfda": {"upc": ["0363323307516"], "unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["8cfeb84f-193a-458a-bdec-205d9274e1a4"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [], "brand_name": "Tobramycin", "product_id": "63323-307_69344ccc-5426-4a9d-9458-1e54f005518f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-307", "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": "ANDA065120", "marketing_category": "ANDA", "marketing_start_date": "20041130", "listing_expiration_date": "20261231"}