gentamicin sulfate

Generic: gentamicin sulfate

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

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler asclemed usa, inc.
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
Asclemed USA, Inc.

Identifiers & Regulatory

Product NDC 76420-137
Product ID 76420-137_d96467a9-dbc5-20ab-e053-2a95a90addb8
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062196
Listing Expiration 2026-12-31
Marketing Start 1996-04-05

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 76420137
Hyphenated Format 76420-137

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 ANDA062196 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOTTLE, PLASTIC (76420-137-05)
source: ndc

Packages (1)

76420-137-05 5 mL in 1 BOTTLE, PLASTIC (76420-137-05)

Ingredients (1)

gentamicin sulfate (3 mg/mL)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "d96467a9-dbc5-20ab-e053-2a95a90addb8", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["a54e5c95-609d-4d66-9573-5d1ac78fa58f"], "manufacturer_name": ["Asclemed USA, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, PLASTIC (76420-137-05)", "package_ndc": "76420-137-05", "marketing_start_date": "20220304"}], "brand_name": "Gentamicin Sulfate", "product_id": "76420-137_d96467a9-dbc5-20ab-e053-2a95a90addb8", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "76420-137", "generic_name": "Gentamicin Sulfate", "labeler_name": "Asclemed USA, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA062196", "marketing_category": "ANDA", "marketing_start_date": "19960405", "listing_expiration_date": "20261231"}