gentamicin sulfate opth solution (72189-359)

Drug Facts

Product Profile

Brand Name gentamicin sulfate opth solution

Generic Name gentamicin sulfate opth solution

Labeler direct_rx

Dosage Form SOLUTION/ DROPS

Routes

OPHTHALMIC

Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer

Direct_Rx

Identifiers & Regulatory

Product NDC 72189-359

Product ID 72189-359_2c4c8caf-089b-acf6-e063-6294a90a14c3

Product Type HUMAN PRESCRIPTION DRUG

Marketing Category ANDA

Application Number ANDA064048

Listing Expiration 2026-12-31

Marketing Start 2022-06-17

Pharmacologic Class

Classes

aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 72189359

Hyphenated Format 72189-359

Supplemental Identifiers

RxCUI

310467

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 opth solution (source: ndc)

Generic Name gentamicin sulfate opth solution (source: ndc)

Application Number ANDA064048 (source: ndc)

Routes

OPHTHALMIC

source: ndc

Resolved Composition

Strengths

3 mg/mL

source: ndc

Packaging

5 mL in 1 BOTTLE, DROPPER (72189-359-05)

source: ndc

Packages (1)

72189-359-05 5 mL in 1 BOTTLE, DROPPER (72189-359-05)

Ingredients (1)

gentamicin sulfate (3 mg/mL)

Linked Drug Pages (1)

Gentamicin Sulfate Opth Solution ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload

{"route": ["OPHTHALMIC"], "spl_id": "2c4c8caf-089b-acf6-e063-6294a90a14c3", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["e1a5bc32-f9a0-6b33-e053-2995a90ab9ac"], "manufacturer_name": ["Direct_Rx"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 BOTTLE, DROPPER (72189-359-05)", "package_ndc": "72189-359-05", "marketing_start_date": "20220617"}], "brand_name": "Gentamicin Sulfate Opth Solution", "product_id": "72189-359_2c4c8caf-089b-acf6-e063-6294a90a14c3", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "72189-359", "generic_name": "Gentamicin Sulfate Opth Solution", "labeler_name": "Direct_Rx", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate Opth Solution", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA064048", "marketing_category": "ANDA", "marketing_start_date": "20220617", "listing_expiration_date": "20261231"}