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United States · US · US:0409-3578_d69232fd-aeae-44b9-9e43-2f2e5bd843be

TOBRAMYCIN

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

ManufacturerHospira, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    0409357801
    25 VIAL, MULTI-DOSE in 1 TRAY (0409-3578-01) / 2 mL in 1 VIAL, MULTI-DOSE (0409-3578-11)

Annotations

UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A063111
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": "0409-3578_d69232fd-aeae-44b9-9e43-2f2e5bd843be",
  "productndc": "0409-3578",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "063111",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/ML",
        "product_no": "001",
        "approval_date": "Apr 30, 1991"
      }
    ],
    "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": "ANDA063111",
  "marketing_category": "ANDA",
  "nonproprietary_name": "TOBRAMYCIN",
  "start_marketing_date": "20050505",
  "active_numerator_strength": "40"
}

Related drugs

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