gentamicin

Generic: gentamicin sulfate

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

Drug Facts

Product Profile

Brand Name gentamicin
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 0404-9866
Product ID 0404-9866_65ca54d7-de8c-4c5f-b47e-393f24de2af9
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062366
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 04049866
Hyphenated Format 0404-9866

Supplemental Identifiers

RxCUI
313996
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 (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA062366 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSE
source: ndc

Packages (1)

0404-9866-20 1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20) / 20 mL in 1 VIAL, MULTI-DOSE

Ingredients (1)

gentamicin sulfate (40 mg/mL)

Linked Drug Pages (1)

Gentamicin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "65ca54d7-de8c-4c5f-b47e-393f24de2af9", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["313996"], "spl_set_id": ["84f6eb1c-a287-489a-8c3e-aa5954cf1992"], "manufacturer_name": ["Henry Schein, Inc"]}, "finished": true, "packaging": [{"sample": false, "description": "1 VIAL, MULTI-DOSE in 1 BAG (0404-9866-20)  / 20 mL in 1 VIAL, MULTI-DOSE", "package_ndc": "0404-9866-20", "marketing_start_date": "20220110"}], "brand_name": "Gentamicin", "product_id": "0404-9866_65ca54d7-de8c-4c5f-b47e-393f24de2af9", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0404-9866", "generic_name": "Gentamicin Sulfate", "labeler_name": "Henry Schein, Inc", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA062366", "marketing_category": "ANDA", "marketing_start_date": "20220110", "listing_expiration_date": "20261231"}