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United States · US · US:72603-160_3f7a227f-2fe6-52d8-e063-6294a90a2838

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

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

Packs · 1

  • ndc11
    7260316006
    6 VIAL, PHARMACY BULK PACKAGE in 1 CARTON (72603-160-06) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (72603-160-01)

Annotations

UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A211189
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": "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": "72603-160_3f7a227f-2fe6-52d8-e063-6294a90a2838",
  "productndc": "72603-160",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "211189",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.2GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "May 18, 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": "g/30mL",
  "application_number": "ANDA211189",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "1.2"
}

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