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United States · US · US:71872-7311_09cf496c-8177-ebb7-e063-6394a90a745a

Gentamicin

Orange BookUNIISPLATC J01GB03

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerMedical Purchasing Solutions, LLC
CountryUS (United States)
ATC codeJ01GB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7187273111
    1 VIAL in 1 BAG (71872-7311-1) / 2 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A062366
APAP
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": "INTRAMUSCULAR; INTRAVENOUS",
  "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": "71872-7311_09cf496c-8177-ebb7-e063-6394a90a745a",
  "productndc": "71872-7311",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "062366",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/ML",
        "product_no": "001",
        "approval_date": "Aug 4, 1983"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "002",
        "approval_date": "Feb 6, 1986"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GENTAMICIN SULFATE",
  "proprietary_name": "Gentamicin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA062366",
  "marketing_category": "ANDA",
  "nonproprietary_name": "GENTAMICIN SULFATE",
  "start_marketing_date": "20000810",
  "active_numerator_strength": "40"
}

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