gentamicin sulfate

Generic: gentamicin sulfate

Labeler: direct rx
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler direct rx
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
DIRECT RX

Identifiers & Regulatory

Product NDC 61919-106
Product ID 61919-106_0e997972-7ec7-5a7a-e063-6294a90aceac
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062452
Listing Expiration 2026-12-31
Marketing Start 2014-01-01

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61919106
Hyphenated Format 61919-106

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 (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 CARTON (61919-106-05)
source: ndc

Packages (1)

61919-106-05 5 mL in 1 CARTON (61919-106-05)

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": "0e997972-7ec7-5a7a-e063-6294a90aceac", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["51a411a0-2671-4c1c-bf25-e29b32efed0c"], "manufacturer_name": ["DIRECT RX"]}, "finished": true, "packaging": [{"sample": false, "description": "5 mL in 1 CARTON (61919-106-05)", "package_ndc": "61919-106-05", "marketing_start_date": "20150507"}], "brand_name": "gentamicin sulfate", "product_id": "61919-106_0e997972-7ec7-5a7a-e063-6294a90aceac", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "61919-106", "generic_name": "gentamicin sulfate", "labeler_name": "DIRECT RX", "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": "20140101", "listing_expiration_date": "20261231"}