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United States · US · US:63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b

Gentak

Orange BookUNIISPLATC J01GB03

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

Identification

ManufacturerProficient Rx LP
CountryUS (United States)
ATC codeJ01GB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6318787335
    1 TUBE in 1 CARTON (63187-873-35) / 3.5 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A064093
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": {
    "1ab0eecf-5ce2-c2bc-e063-6394a90a744b": {
      "match": "brand_token",
      "title": "GENTAK (GENTAMICIN SULFATE) OINTMENT [REDPHARM DRUG]",
      "spl_version": "1",
      "published_date": "2024-06-13"
    }
  },
  "productid": "63187-873_57dbd129-b76f-49e6-b76a-eb86ad22273b",
  "productndc": "63187-873",
  "dosage_form": "OINTMENT",
  "orange_book": {
    "appl_no": "064093",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "EQ 0.3% BASE",
        "product_no": "001",
        "approval_date": "Aug 31, 1995"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GENTAMICIN SULFATE",
  "proprietary_name": "Gentak",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA064093",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gentamicin Sulfate",
  "start_marketing_date": "20060508",
  "active_numerator_strength": "3"
}

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