gentamicin sulfate

Generic: gentamicin sulfate

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

Drug Facts

Product Profile

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

gentamicin sulfate 3 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4775
Product ID 68071-4775_1adbfbb6-92b8-3288-e063-6394a90a6f29
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 680714775
Hyphenated Format 68071-4775

Supplemental Identifiers

RxCUI
310467
UPC
0368071477559
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 (68071-4775-5)
source: ndc

Packages (1)

68071-4775-5 5 mL in 1 BOTTLE (68071-4775-5)

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": "1adbfbb6-92b8-3288-e063-6394a90a6f29", "openfda": {"upc": ["0368071477559"], "unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["82595309-304e-a221-e053-2991aa0ac0a9"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE (68071-4775-5)", "package_ndc": "68071-4775-5", "marketing_start_date": "20190220"}], "brand_name": "Gentamicin Sulfate", "product_id": "68071-4775_1adbfbb6-92b8-3288-e063-6394a90a6f29", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "68071-4775", "generic_name": "Gentamicin Sulfate", "labeler_name": "NuCare Pharmaceuticals,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"}