gentamicin

Generic: gentamicin

Labeler: hikma pharmaceuticals usa inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin
Generic Name gentamicin
Labeler hikma pharmaceuticals usa inc.
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

gentamicin sulfate 40 mg/mL

Manufacturer
Hikma Pharmaceuticals USA Inc.

Identifiers & Regulatory

Product NDC 0143-9129
Product ID 0143-9129_9908273d-c700-4036-82fe-312f25a8aacd
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062251
Listing Expiration 2026-12-31
Marketing Start 2022-02-15

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 01439129
Hyphenated Format 0143-9129

Supplemental Identifiers

RxCUI
313996
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 ANDA062251 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01)
source: ndc

Packages (1)

0143-9129-10 10 VIAL in 1 CARTON (0143-9129-10) / 20 mL in 1 VIAL (0143-9129-01)

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": "9908273d-c700-4036-82fe-312f25a8aacd", "openfda": {"unii": ["8X7386QRLV"], "rxcui": ["313996"], "spl_set_id": ["51fffac8-fb6e-4f7f-b2de-440252781a42"], "manufacturer_name": ["Hikma Pharmaceuticals USA Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "10 VIAL in 1 CARTON (0143-9129-10)  / 20 mL in 1 VIAL (0143-9129-01)", "package_ndc": "0143-9129-10", "marketing_start_date": "20220215"}], "brand_name": "Gentamicin", "product_id": "0143-9129_9908273d-c700-4036-82fe-312f25a8aacd", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "0143-9129", "generic_name": "Gentamicin", "labeler_name": "Hikma Pharmaceuticals USA Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA062251", "marketing_category": "ANDA", "marketing_start_date": "20220215", "listing_expiration_date": "20261231"}