gentamicin sulfate

Generic: gentamicin sulfate

Labeler: proficient rx lp
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name gentamicin sulfate
Generic Name gentamicin sulfate
Labeler proficient rx lp
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

gentamicin sulfate 3 mg/mL

Manufacturer
Proficient Rx LP

Identifiers & Regulatory

Product NDC 63187-163
Product ID 63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA062452
Listing Expiration 2026-12-31
Marketing Start 1998-01-05

Pharmacologic Class

Classes
aminoglycoside antibacterial [epc] aminoglycosides [cs]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 63187163
Hyphenated Format 63187-163

Supplemental Identifiers

RxCUI
310467
UPC
0363187163051
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 sulfate (source: ndc)
Generic Name gentamicin sulfate (source: ndc)
Application Number ANDA062452 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 3 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, DROPPER in 1 CARTON (63187-163-05) / 5 mL in 1 BOTTLE, DROPPER
source: ndc

Packages (1)

63187-163-05 1 BOTTLE, DROPPER in 1 CARTON (63187-163-05) / 5 mL in 1 BOTTLE, DROPPER

Ingredients (1)

gentamicin sulfate (3 mg/mL)

Linked Drug Pages (1)

GENTAMICIN SULFATE ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "9bc97257-3fe5-45aa-a544-78d044982cd4", "openfda": {"upc": ["0363187163051"], "unii": ["8X7386QRLV"], "rxcui": ["310467"], "spl_set_id": ["3ab508ed-4b12-4dd7-a13e-1a071f560286"], "manufacturer_name": ["Proficient Rx LP"]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, DROPPER in 1 CARTON (63187-163-05)  / 5 mL in 1 BOTTLE, DROPPER", "package_ndc": "63187-163-05", "marketing_start_date": "20190101"}], "brand_name": "GENTAMICIN SULFATE", "product_id": "63187-163_9bc97257-3fe5-45aa-a544-78d044982cd4", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Aminoglycoside Antibacterial [EPC]", "Aminoglycosides [CS]"], "product_ndc": "63187-163", "generic_name": "gentamicin sulfate", "labeler_name": "Proficient Rx LP", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "GENTAMICIN SULFATE", "active_ingredients": [{"name": "GENTAMICIN SULFATE", "strength": "3 mg/mL"}], "application_number": "ANDA062452", "marketing_category": "ANDA", "marketing_start_date": "19980105", "listing_expiration_date": "20261231"}