Gentamicin Sulfate in Sodium Chloride

Orange BookUNIISPLATC J01GB03

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

Identification

ManufacturerBaxter Healthcare Corporation

CountryUS (United States)

ATC codeJ01GB03

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0338050348
100 mL in 1 BAG (0338-0503-48)

Annotations

UNII (FDA Substance ID)

8X7386QRLV

GENTAMICIN SULFATE

RxCUI 1870193

Orange Book

A062373

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": "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": "0338-0503_aacff3ac-5df9-4872-b074-78930c9c9b79",
  "productndc": "0338-0503",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "062373",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.8MG BASE/ML",
        "product_no": "001",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 80MG BASE/100ML",
        "product_no": "002",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 40MG BASE/100ML",
        "product_no": "003",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 60MG BASE/100ML",
        "product_no": "004",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 100MG BASE/100ML",
        "product_no": "005",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 120MG BASE/100ML",
        "product_no": "006",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1.2MG BASE/ML",
        "product_no": "007",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 1.6MG BASE/ML",
        "product_no": "008",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": true,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2MG BASE/ML",
        "product_no": "009",
        "approval_date": "Sep 7, 1982"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 2.4MG BASE/ML",
        "product_no": "010",
        "approval_date": "Sep 7, 1982"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GENTAMICIN SULFATE",
  "proprietary_name": "Gentamicin Sulfate in Sodium Chloride",
  "active_ingred_unit": "mg/100mL",
  "application_number": "ANDA062373",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gentamicin Sulfate",
  "start_marketing_date": "19820907",
  "active_numerator_strength": "80"
}

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