gentamicin sulfate

Generic: gentamicin sulfate

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

Drug Facts

Product Profile

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

gentamicin sulfate 40 mg/mL

Manufacturer
Hospira, Inc.

Identifiers & Regulatory

Product NDC 0409-1207
Product ID 0409-1207_90119984-4be7-494f-9ba0-61ec49c15143
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062420
Listing Expiration 2026-12-31
Marketing Start 2005-08-29

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04091207
Hyphenated Format 0409-1207

Supplemental Identifiers

RxCUI
1870650
UNII
8X7386QRLV

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 gentamicin sulfate (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA062420 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13)
source: ndc

Packages (1)

0409-1207-03 25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03) / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13)

Ingredients (1)

gentamicin sulfate (40 mg/mL)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "90119984-4be7-494f-9ba0-61ec49c15143", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["1870650"], "spl_set_id": ["977180b3-a222-4282-d485-4a3217674305"], "manufacturer_name": ["Hospira, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, SINGLE-DOSE in 1 TRAY (0409-1207-03)  / 2 mL in 1 VIAL, SINGLE-DOSE (0409-1207-13)", "package_ndc": "0409-1207-03", "marketing_start_date": "20050829"}], "brand_name": "Gentamicin Sulfate", "product_id": "0409-1207_90119984-4be7-494f-9ba0-61ec49c15143", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0409-1207", "generic_name": "GENTAMICIN SULFATE", "labeler_name": "Hospira, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA062420", "marketing_category": "ANDA", "marketing_start_date": "20050829", "listing_expiration_date": "20261231"}