Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

ManufacturerGland Pharma Limited

CountryUS (United States)

ATC codeJ01GB01

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
6808325325
25 VIAL, MULTI-DOSE in 1 CARTON (68083-253-25) / 2 mL in 1 VIAL, MULTI-DOSE (68083-253-01)

Annotations

UNII (FDA Substance ID)

HJT0RXD7JK

TOBRAMYCIN SULFATE

RxCUI 7276

Orange Book

A209621

APAP

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": "68083-253_5af7f80d-4d6d-404f-9ff7-1a8315625d8b",
  "productndc": "68083-253",
  "dosage_form": "INJECTION",
  "orange_book": {
    "appl_no": "209621",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 10MG BASE/ML",
        "product_no": "001",
        "approval_date": "Feb 11, 2021"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 40MG BASE/ML",
        "product_no": "002",
        "approval_date": "Feb 11, 2021"
      }
    ],
    "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": "ANDA209621",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "20210211",
  "active_numerator_strength": "10"
}

Related drugs

Other records sharing ATC code J01GB01.

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