gentamicin sulfate

Generic: gentamicin sulfate

Labeler: henry schein, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler henry schein, inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

gentamicin sulfate 40 mg/mL

Manufacturer
Henry Schein, Inc.

Identifiers & Regulatory

Product NDC 0404-9865
Product ID 0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062420
Listing Expiration 2026-12-31
Marketing Start 2022-01-10

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 04049865
Hyphenated Format 0404-9865

Supplemental Identifiers

RxCUI
1870650
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 ANDA062420 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02) / 2 mL in 1 VIAL, SINGLE-DOSE
source: ndc

Packages (1)

0404-9865-02 1 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02) / 2 mL in 1 VIAL, SINGLE-DOSE

Ingredients (1)

gentamicin sulfate (40 mg/mL)

Linked Drug Pages (1)

Gentamicin Sulfate ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "fa19ae2a-f30b-484f-b702-0e13b5431c33", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["1870650"], "spl_set_id": ["913a36c3-50d6-429a-a8dd-a03126d2ca08"], "manufacturer_name": ["Henry Schein, Inc."]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, SINGLE-DOSE in 1 BAG (0404-9865-02)  / 2 mL in 1 VIAL, SINGLE-DOSE", "package_ndc": "0404-9865-02", "marketing_start_date": "20220110"}], "brand_name": "Gentamicin Sulfate", "product_id": "0404-9865_fa19ae2a-f30b-484f-b702-0e13b5431c33", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0404-9865", "generic_name": "Gentamicin Sulfate", "labeler_name": "Henry Schein, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin Sulfate", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA062420", "marketing_category": "ANDA", "marketing_start_date": "20220110", "listing_expiration_date": "20261231"}