gentamicin sulfate

Generic: gentamicin sulfate

Labeler: padagis israel pharmaceuticals ltd
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler padagis israel pharmaceuticals ltd
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

gentamicin sulfate 1 mg/g

Manufacturer
Padagis Israel Pharmaceuticals Ltd

Identifiers & Regulatory

Product NDC 45802-046
Product ID 45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062351
Listing Expiration 2026-12-31
Marketing Start 2006-07-10

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 45802046
Hyphenated Format 45802-046

Supplemental Identifiers

RxCUI
310465
UNII
8X7386QRLV

Packaging Origin

Original Packager
true

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 ANDA062351 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBE
  • 1 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBE
source: ndc

Packages (2)

45802-046-11 1 TUBE in 1 CARTON (45802-046-11) / 30 g in 1 TUBE 45802-046-35 1 TUBE in 1 CARTON (45802-046-35) / 15 g in 1 TUBE

Ingredients (1)

gentamicin sulfate (1 mg/g)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "551f1c2e-36a3-4229-b70f-38b6a3faa1d5", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310465"], "spl_set_id": ["a9486ae1-350b-41c5-ae0c-a4d692bb2dfd"], "manufacturer_name": ["Padagis Israel Pharmaceuticals Ltd"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (45802-046-11)  / 30 g in 1 TUBE", "package_ndc": "45802-046-11", "marketing_start_date": "20060828"}, {"sample": false, "description": "1 TUBE in 1 CARTON (45802-046-35)  / 15 g in 1 TUBE", "package_ndc": "45802-046-35", "marketing_start_date": "20060710"}], "brand_name": "Gentamicin Sulfate", "product_id": "45802-046_551f1c2e-36a3-4229-b70f-38b6a3faa1d5", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "45802-046", "generic_name": "Gentamicin Sulfate", "labeler_name": "Padagis Israel Pharmaceuticals Ltd", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "1 mg/g"}], "application_number": "ANDA062351", "marketing_category": "ANDA", "marketing_start_date": "20060710", "listing_expiration_date": "20261231"}