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United States · US · US:0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c

Gentamicin Sulfate

Orange BookUNIISPLATC J01GB03

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

Identification

ManufacturerCosette Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeJ01GB03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0713068315
    1 TUBE in 1 CARTON (0713-0683-15) / 15 g in 1 TUBE
  • ndc11
    0713068331
    1 TUBE in 1 CARTON (0713-0683-31) / 30 g in 1 TUBE

Annotations

UNII (FDA Substance ID)
8X7386QRLV
GENTAMICIN SULFATE
RxCUI 1870193
Orange Book
A064056
AT
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": "TOPICAL",
  "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": "0713-0683_0abc5db4-9344-8946-e063-6394a90abf1c",
  "productndc": "0713-0683",
  "dosage_form": "CREAM",
  "orange_book": {
    "appl_no": "064056",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "EQ 0.1% BASE",
        "product_no": "001",
        "approval_date": "Apr 29, 1994"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "GENTAMICIN SULFATE",
  "proprietary_name": "Gentamicin Sulfate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA064056",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Gentamicin Sulfate",
  "start_marketing_date": "20161111",
  "active_numerator_strength": "1"
}

Related drugs

Other records sharing ATC code J01GB03.

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