gentamicin

Generic: gentamicin

Labeler: eugia us llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin
Generic Name gentamicin
Labeler eugia us llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

gentamicin sulfate 40 mg/mL

Manufacturer
Eugia US LLC

Identifiers & Regulatory

Product NDC 55150-403
Product ID 55150-403_c72dacd5-33b4-456e-ad96-0e8635a73854
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA215237
Listing Expiration 2027-12-31
Marketing Start 2024-01-08

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 55150403
Hyphenated Format 55150-403

Supplemental Identifiers

RxCUI
313996
UPC
0355150403257
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 ANDA215237 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 VIAL, MULTI-DOSE in 1 CARTON (55150-403-25) / 20 mL in 1 VIAL, MULTI-DOSE (55150-403-01)
source: ndc

Packages (1)

55150-403-25 25 VIAL, MULTI-DOSE in 1 CARTON (55150-403-25) / 20 mL in 1 VIAL, MULTI-DOSE (55150-403-01)

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": "c72dacd5-33b4-456e-ad96-0e8635a73854", "openfda": {"upc": ["0355150403257"], "unii": ["8X7386QRLV"], "rxcui": ["313996"], "spl_set_id": ["60ca1487-392d-4721-aa45-3de38722896c"], "manufacturer_name": ["Eugia US LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL, MULTI-DOSE in 1 CARTON (55150-403-25)  / 20 mL in 1 VIAL, MULTI-DOSE (55150-403-01)", "package_ndc": "55150-403-25", "marketing_start_date": "20240108"}], "brand_name": "Gentamicin", "product_id": "55150-403_c72dacd5-33b4-456e-ad96-0e8635a73854", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "55150-403", "generic_name": "Gentamicin", "labeler_name": "Eugia US LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Gentamicin", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "40 mg/mL"}], "application_number": "ANDA215237", "marketing_category": "ANDA", "marketing_start_date": "20240108", "listing_expiration_date": "20271231"}