gentamicin

Generic: gentamicin

Labeler: fresenius kabi usa, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin
Generic Name gentamicin
Labeler fresenius kabi usa, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

gentamicin sulfate 10 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-173
Product ID 63323-173_9f48c9f7-08fd-4652-911c-c2c221a34ed3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062366
Listing Expiration 2026-12-31
Marketing Start 2004-11-29

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323173
Hyphenated Format 63323-173

Supplemental Identifiers

RxCUI
1870676
UPC
0363323173951
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 (source: ndc)
Generic Name gentamicin (source: ndc)
Application Number ANDA062366 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 10 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 TRAY (63323-173-95) / 2 mL in 1 VIAL
source: ndc

Packages (1)

63323-173-95 25 VIAL in 1 TRAY (63323-173-95) / 2 mL in 1 VIAL

Ingredients (1)

gentamicin sulfate (10 mg/mL)

Linked Drug Pages (3)

Gentamicin ndc-match (0.9) Gentamicin ndc-match (0.9) Gentamicin ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAMUSCULAR", "INTRAVENOUS"], "spl_id": "9f48c9f7-08fd-4652-911c-c2c221a34ed3", "openfda": {"upc": ["0363323173951"], "unii": ["8X7386QRLV"], "rxcui": ["1870676"], "spl_set_id": ["63413469-c676-48a3-a945-7d2489b535ef"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 TRAY (63323-173-95)  / 2 mL in 1 VIAL", "package_ndc": "63323-173-95", "marketing_start_date": "20041129"}], "brand_name": "Gentamicin", "product_id": "63323-173_9f48c9f7-08fd-4652-911c-c2c221a34ed3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-173", "generic_name": "GENTAMICIN", "labeler_name": "Fresenius Kabi USA, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "10 mg/mL"}], "application_number": "ANDA062366", "marketing_category": "ANDA", "marketing_start_date": "20041129", "listing_expiration_date": "20261231"}