GENTAMICIN SULFATE

Generic: gentamicin sulfate

Labeler: Pacific Pharma, Inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Active

Drug Facts

Product Profile

Brand Name GENTAMICIN SULFATE
Generic Name gentamicin sulfate
Labeler Pacific Pharma, Inc.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

GENTAMICIN SULFATE 3 mg/mL

Identifiers & Regulatory

Product NDC 60758-188
Product ID 60758-188_0b295ef8-52d7-4199-91f4-53838936257a
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062452
Listing Expiration 2026-12-31
Marketing Start 1998-01-05

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 60758188
Hyphenated Format 60758-188

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 ANDA062452 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

60758-188-05 1 BOTTLE, DROPPER in 1 CARTON (60758-188-05) / 5 mL in 1 BOTTLE, DROPPER

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": "0b295ef8-52d7-4199-91f4-53838936257a", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["0bc9fa00-1755-4989-a222-a038e970371f"], "manufacturer_name": ["Pacific Pharma, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (60758-188-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "60758-188-05", "marketing_start_date": "19980105"}], "brand_name": "GENTAMICIN SULFATE", "product_id": "60758-188_0b295ef8-52d7-4199-91f4-53838936257a", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "60758-188", "generic_name": "gentamicin sulfate", "labeler_name": "Pacific Pharma, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GENTAMICIN SULFATE", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA062452", "marketing_category": "ANDA", "marketing_start_date": "19980105", "listing_expiration_date": "20261231"}