gentamicin sulfate in sodium chloride

Generic: gentamicin sulfate

Labeler: baxter healthcare corporation
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate in sodium chloride
Generic Name gentamicin sulfate
Labeler baxter healthcare corporation
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

gentamicin sulfate 60 mg/50mL

Manufacturer
Baxter Healthcare Corporation

Identifiers & Regulatory

Product NDC 0338-0507
Product ID 0338-0507_1853c7b2-32b0-487c-9d3c-7e884858ac7b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062373
Listing Expiration 2026-12-31
Marketing Start 1982-09-07

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 03380507
Hyphenated Format 0338-0507

Supplemental Identifiers

RxCUI
197736 242816 310473 310477 1870631 1870633
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 in sodium chloride (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA062373 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 60 mg/50mL
source: ndc
Packaging
  • 50 mL in 1 BAG (0338-0507-41)
  • 100 mL in 1 BAG (0338-0507-48)
source: ndc

Packages (2)

0338-0507-41 50 mL in 1 BAG (0338-0507-41) 0338-0507-48 100 mL in 1 BAG (0338-0507-48)

Ingredients (1)

gentamicin sulfate (60 mg/50mL)

Linked Drug Pages (1)

Gentamicin Sulfate in Sodium Chloride ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "1853c7b2-32b0-487c-9d3c-7e884858ac7b", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["197736", "242816", "310473", "310477", "1870631", "1870633"], "spl_set_id": ["449c9a41-d61e-49fd-b5e3-d76f74b92acf"], "manufacturer_name": ["Baxter Healthcare Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "50 mL in 1 BAG (0338-0507-41)", "package_ndc": "0338-0507-41", "marketing_start_date": "19820907"}, {"sample": false, "description": "100 mL in 1 BAG (0338-0507-48)", "package_ndc": "0338-0507-48", "marketing_start_date": "19820907"}], "brand_name": "Gentamicin Sulfate in Sodium Chloride", "product_id": "0338-0507_1853c7b2-32b0-487c-9d3c-7e884858ac7b", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0338-0507", "generic_name": "Gentamicin Sulfate", "labeler_name": "Baxter Healthcare Corporation", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate in Sodium Chloride", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "60 mg/50mL"}], "application_number": "ANDA062373", "marketing_category": "ANDA", "marketing_start_date": "19820907", "listing_expiration_date": "20261231"}