gentamicin sulfate

Generic: gentamicin sulfate

Labeler: a-s medication solutions
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler a-s medication solutions
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
A-S Medication Solutions

Identifiers & Regulatory

Product NDC 50090-0569
Product ID 50090-0569_704bbbf7-8b57-4cb3-830c-def5e334618d
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064048
Listing Expiration 2026-12-31
Marketing Start 1994-05-11

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 500900569
Hyphenated Format 50090-0569

Supplemental Identifiers

RxCUI
310467
UNII
8X7386QRLV

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 ANDA064048 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (50090-0569-0) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

Ingredients (1)

gentamicin sulfate (3 mg/mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["OPHTHALMIC"], "spl_id": "704bbbf7-8b57-4cb3-830c-def5e334618d", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["76fabcd6-4da3-49e3-85a1-ca4fac55a207"], "manufacturer_name": ["A-S Medication Solutions"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (50090-0569-0)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "50090-0569-0", "marketing_start_date": "20160629"}], "brand_name": "Gentamicin Sulfate", "product_id": "50090-0569_704bbbf7-8b57-4cb3-830c-def5e334618d", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "50090-0569", "generic_name": "Gentamicin Sulfate", "labeler_name": "A-S Medication Solutions", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA064048", "marketing_category": "ANDA", "marketing_start_date": "19940511", "listing_expiration_date": "20261231"}