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United States · US · US:50090-2127_9aee4577-c7ea-43b9-bcfc-94ac6c98608c

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

ManufacturerA-S Medication Solutions
CountryUS (United States)
ATC codeJ01GB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    5009021270
    1 BOTTLE, DROPPER in 1 CARTON (50090-2127-0) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A064052
AT
DailyMed SPL labels
1 version tracked
FDA shortage
Currently in shortage
Tobramycin Solution
Raw payload (JSON)
{
  "unii": {
    "unii": "VZ8RRZ51VK",
    "rxcui": "10627",
    "inchikey": "NLVFBUXFDBBNBW-PBSUHMDJSA-N",
    "display_name": "TOBRAMYCIN",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "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": "50090-2127_9aee4577-c7ea-43b9-bcfc-94ac6c98608c",
  "productndc": "50090-2127",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "064052",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Nov 29, 1993"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "TOBRAMYCIN",
  "shortage_reason": "Tobramycin Solution",
  "shortage_status": "current",
  "proprietary_name": "Tobramycin",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA064052",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "19931129",
  "active_numerator_strength": "3"
}

Related drugs

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