tobramycin

Generic: tobramycin

Labeler: hospira, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler hospira, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

tobramycin sulfate 40 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-3578
Product ID 0409-3578_74f907dc-5692-48e6-b734-64aa63e89c7f
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA063111
Listing Expiration 2026-12-31
Marketing Start 2005-05-05

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04093578
Hyphenated Format 0409-3578

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 (source: ndc)
Application Number ANDA063111 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11)
source: ndc

Packages (1)

0409-3578-01 25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11)

Ingredients (1)

tobramycin sulfate (40 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": "74f907dc-5692-48e6-b734-64aa63e89c7f", "openfda": {"unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["c5a005b0-7b6f-4e30-df92-9a20b1ca66a1"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01)  / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11)", "package_ndc": "0409-3578-01", "marketing_start_date": "20050505"}], "brand_name": "TOBRAMYCIN", "product_id": "0409-3578_74f907dc-5692-48e6-b734-64aa63e89c7f", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0409-3578", "generic_name": "TOBRAMYCIN", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "TOBRAMYCIN", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA063111", "marketing_category": "ANDA", "marketing_start_date": "20050505", "listing_expiration_date": "20261231"}