gentak

Generic: gentamicin sulfate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentak
Generic Name gentamicin sulfate
Labeler proficient rx lp
Dosage Form OINTMENT
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/g

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-873
Product ID 63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA064093
Listing Expiration 2026-12-31
Marketing Start 2006-05-08

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187873
Hyphenated Format 63187-873

Supplemental Identifiers

RxCUI
310466 545236
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 gentak (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA064093 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE
source: ndc

Packages (1)

63187-873-35 1 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE

Ingredients (1)

gentamicin sulfate (3 mg/g)

Linked Drug Pages (1)

Gentak ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "57dbd129-b76f-49e6-b76a-eb86ad22273b", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310466", "545236"], "spl_set_id": ["aebfe247-cdf7-4acb-97b3-6d4341d7c815"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (63187-873-35)  / 3.5 g in 1 TUBE", "package_ndc": "63187-873-35", "marketing_start_date": "20170703"}], "brand_name": "Gentak", "product_id": "63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b", "dosage_form": "OINTMENT", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63187-873", "generic_name": "Gentamicin Sulfate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentak", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/g"}], "application_number": "ANDA064093", "marketing_category": "ANDA", "marketing_start_date": "20060508", "listing_expiration_date": "20261231"}