gentamicin sulfate

Generic: gentamicin sulfate

Labeler: sandoz inc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler sandoz inc
Dosage Form SOLUTION
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
Sandoz Inc

Identifiers & Regulatory

Product NDC 61314-633
Product ID 61314-633_a628d79b-79de-49ec-b116-c605ba0fb991
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062196
Listing Expiration 2026-12-31
Marketing Start 1996-04-05

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 61314633
Hyphenated Format 61314-633

Supplemental Identifiers

RxCUI
310467
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 ANDA062196 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

61314-633-05 1 BOTTLE, DROPPER in 1 CARTON (61314-633-05) / 5 mL in 1 BOTTLE, DROPPER

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": "a628d79b-79de-49ec-b116-c605ba0fb991", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["a213fb9c-08ea-4f30-a6c9-93c7a9ba5280"], "manufacturer_name": ["Sandoz Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (61314-633-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "61314-633-05", "marketing_start_date": "19960405"}], "brand_name": "Gentamicin Sulfate", "product_id": "61314-633_a628d79b-79de-49ec-b116-c605ba0fb991", "dosage_form": "SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "61314-633", "generic_name": "Gentamicin Sulfate", "labeler_name": "Sandoz Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA062196", "marketing_category": "ANDA", "marketing_start_date": "19960405", "listing_expiration_date": "20261231"}