tobramycin

Generic: tobramycin

Labeler: mylan institutional llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name tobramycin
Generic Name tobramycin
Labeler mylan institutional llc
Dosage Form INJECTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

tobramycin sulfate 40 mg/mL

Manufacturer
Mylan Institutional LLC

Identifiers & Regulatory

Product NDC 67457-473
Product ID 67457-473_7418acd9-03c9-40ed-bac0-1e0702c8114d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA065407
Listing Expiration 2026-12-31
Marketing Start 2014-08-19

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 67457473
Hyphenated Format 67457-473

Supplemental Identifiers

RxCUI
597823
UPC
0367457428307 0367457473222
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 ANDA065407 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00)
source: ndc

Packages (1)

67457-473-22 25 VIAL in 1 CARTON (67457-473-22) / 2 mL in 1 VIAL (67457-473-00)

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": "7418acd9-03c9-40ed-bac0-1e0702c8114d", "openfda": {"upc": ["0367457428307", "0367457473222"], "unii": ["HJT0RXD7JK"], "rxcui": ["597823"], "spl_set_id": ["ac8134d9-a726-4508-b8b9-a536ef17243d"], "manufacturer_name": ["Mylan Institutional LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (67457-473-22)  / 2 mL in 1 VIAL (67457-473-00)", "package_ndc": "67457-473-22", "marketing_start_date": "20140819"}], "brand_name": "Tobramycin", "product_id": "67457-473_7418acd9-03c9-40ed-bac0-1e0702c8114d", "dosage_form": "INJECTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "67457-473", "generic_name": "Tobramycin", "labeler_name": "Mylan Institutional LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Tobramycin", "active_ingredients": [{"name": "TOBRAMYCIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA065407", "marketing_category": "ANDA", "marketing_start_date": "20140819", "listing_expiration_date": "20261231"}