gentamicin

Generic: gentamicin sulfate

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

Drug Facts

Product Profile

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

gentamicin sulfate 40 mg/mL

Manufacturer
Fresenius Kabi USA, LLC

Identifiers & Regulatory

Product NDC 63323-010
Product ID 63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062366
Listing Expiration 2026-12-31
Marketing Start 2000-08-10

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63323010
Hyphenated Format 63323-010

Supplemental Identifiers

RxCUI
313996
UPC
0363323010423 0363323010416
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 sulfate (source: ndc)
Application Number ANDA062366 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94) / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41)
  • 25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95) / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42)
source: ndc

Packages (2)

63323-010-94 25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94) / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41) 63323-010-95 25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95) / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42)

Ingredients (1)

gentamicin sulfate (40 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": "48a57ed5-3809-49cc-a7ec-715e7e2c1720", "openfda": {"upc": ["0363323010423", "0363323010416"], "unii": ["8X7386QRLV"], "rxcui": ["313996"], "spl_set_id": ["0cce2238-28d3-4280-b520-ffc3067a2ffa"], "manufacturer_name": ["Fresenius Kabi USA, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-94)  / 2 mL in 1 VIAL, MULTI-DOSE (63323-010-41)", "package_ndc": "63323-010-94", "marketing_start_date": "20000810"}, {"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 TRAY (63323-010-95)  / 20 mL in 1 VIAL, MULTI-DOSE (63323-010-42)", "package_ndc": "63323-010-95", "marketing_start_date": "20000810"}], "brand_name": "Gentamicin", "product_id": "63323-010_48a57ed5-3809-49cc-a7ec-715e7e2c1720", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63323-010", "generic_name": "GENTAMICIN SULFATE", "labeler_name": "Fresenius Kabi USA, LLC", "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": "20000810", "listing_expiration_date": "20261231"}