Gentamicin Sulfate Opth Solution

Orange BookUNIISPLATC J01GB03

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerDirect_Rx

CountryUS (United States)

ATC codeJ01GB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
7218935905
5 mL in 1 BOTTLE, DROPPER (72189-359-05)

Annotations

UNII (FDA Substance ID)

8X7386QRLV

GENTAMICIN SULFATE

RxCUI 1870193

Orange Book

A064048

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "8X7386QRLV",
    "rxcui": "1870193",
    "inchikey": null,
    "display_name": "GENTAMICIN SULFATE",
    "substance_type": "mixture",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "977180b3-a222-4282-d485-4a3217674305": {
      "match": "brand_token",
      "title": "GENTAMICIN SULFATE INJECTION, SOLUTION [HOSPIRA, INC.]",
      "spl_version": "22",
      "published_date": "2026-05-22"
    }
  },
  "productid": "72189-359_4d3a9fbe-9f7c-e1a0-e063-6294a90a7857",
  "productndc": "72189-359",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "064048",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "May 11, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GENTAMICIN SULFATE",
  "proprietary_name": "Gentamicin Sulfate Opth Solution",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA064048",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gentamicin Sulfate Opth Solution",
  "start_marketing_date": "20220617",
  "active_numerator_strength": "3"
}

Related drugs

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