gentamicin

Generic: gentamicin

Labeler: hf acquisition co llc, dba healthfirst
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin
Generic Name gentamicin
Labeler hf acquisition co llc, dba healthfirst
Dosage Form INJECTION, SOLUTION
Routes
INTRAMUSCULAR INTRAVENOUS
Active Ingredients

gentamicin sulfate 40 mg/mL

Manufacturer
HF Acquisition Co LLC, DBA HealthFirst

Identifiers & Regulatory

Product NDC 51662-1508
Product ID 51662-1508_1032caaf-e8c2-e3cc-e063-6294a90a47f3
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062366
Listing Expiration 2026-12-31
Marketing Start 2021-05-10

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 516621508
Hyphenated Format 51662-1508

Supplemental Identifiers

RxCUI
313996
UPC
0363323010201
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 (source: ndc)
Application Number ANDA062366 (source: ndc)
Routes
INTRAMUSCULAR INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 40 mg/mL
source: ndc
Packaging
  • 25 POUCH in 1 BOX (51662-1508-3) / 1 VIAL in 1 POUCH (51662-1508-2) / 20 mL in 1 VIAL
source: ndc

Packages (1)

51662-1508-3 25 POUCH in 1 BOX (51662-1508-3) / 1 VIAL in 1 POUCH (51662-1508-2) / 20 mL in 1 VIAL

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": "1032caaf-e8c2-e3cc-e063-6294a90a47f3", "openfda": {"upc": ["0363323010201"], "unii": ["8X7386QRLV"], "rxcui": ["313996"], "spl_set_id": ["c1ff0cdc-ac5d-30ca-e053-2a95a90a5066"], "manufacturer_name": ["HF Acquisition Co LLC, DBA HealthFirst"]}, "finished": true, "packaging": [{"sample": false, "description": "25 POUCH in 1 BOX (51662-1508-3)  / 1 VIAL in 1 POUCH (51662-1508-2)  / 20 mL in 1 VIAL", "package_ndc": "51662-1508-3", "marketing_start_date": "20210510"}], "brand_name": "GENTAMICIN", "product_id": "51662-1508_1032caaf-e8c2-e3cc-e063-6294a90a47f3", "dosage_form": "INJECTION, SOLUTION", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "51662-1508", "generic_name": "GENTAMICIN", "labeler_name": "HF Acquisition Co LLC, DBA HealthFirst", "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": "20210510", "listing_expiration_date": "20261231"}