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/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
NuCare Pharmaceuticals,Inc.

Identifiers & Regulatory

Product NDC 68071-4827
Product ID 68071-4827_1ade255c-bb1d-b03f-e063-6294a90a6d78
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062452
Listing Expiration 2026-12-31
Marketing Start 1998-01-05

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 680714827
Hyphenated Format 68071-4827

Supplemental Identifiers

RxCUI
310467
UPC
0368071482751
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 ANDA062452 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 5 mL in 1 BOX (68071-4827-5)
source: ndc

Packages (1)

68071-4827-5 5 mL in 1 BOX (68071-4827-5)

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": "1ade255c-bb1d-b03f-e063-6294a90a6d78", "openfda": {"upc": ["0368071482751"], "unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["85424b40-5c2d-421d-e053-2991aa0a7771"], "manufacturer_name": ["NuCare Pharmaceuticals,Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOX (68071-4827-5)", "package_ndc": "68071-4827-5", "marketing_start_date": "20190329"}], "brand_name": "GENTAMICIN SULFATE", "product_id": "68071-4827_1ade255c-bb1d-b03f-e063-6294a90a6d78", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "68071-4827", "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": "ANDA062452", "marketing_category": "ANDA", "marketing_start_date": "19980105", "listing_expiration_date": "20261231"}