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United States · US · US:67457-428_7418acd9-03c9-40ed-bac0-1e0702c8114d

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

ManufacturerMylan Institutional LLC
CountryUS (United States)
ATC codeJ01GB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6745742830
    10 VIAL in 1 CARTON (67457-428-30) / 30 mL in 1 VIAL (67457-428-00)

Annotations

UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A065407
AP
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tobramycin Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "HJT0RXD7JK",
    "rxcui": "7276",
    "inchikey": "NZKFUBQRAWPZJP-BXKLGIMVSA-N",
    "display_name": "TOBRAMYCIN SULFATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAMUSCULAR; INTRAVENOUS",
  "spl_meta": {
    "1884ef6f-a60c-4a82-a7dc-fd48b7176db0": {
      "match": "brand_token",
      "title": "TOBRAMYCIN AND DEXAMETHASONE SUSPENSION/ DROPS [BRYANT RANCH PREPACK]",
      "spl_version": "103",
      "published_date": "2026-06-01"
    }
  },
  "productid": "67457-428_7418acd9-03c9-40ed-bac0-1e0702c8114d",
  "productndc": "67457-428",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "065407",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/ML",
        "product_no": "001",
        "approval_date": "Mar 11, 2008"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOBRAMYCIN SULFATE",
  "shortage_reason": "Tobramycin Solution",
  "shortage_status": "current",
  "proprietary_name": "Tobramycin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA065407",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "20140219",
  "active_numerator_strength": "40"
}

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