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United States · US · US:86211-110_c6435b8f-bb6e-45e0-a52b-3087fd043b5a

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

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

Packs · 1

  • ndc11
    8621111001
    1 BOTTLE, PLASTIC in 1 CARTON (86211-110-01) / 5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A212628
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": "86211-110_c6435b8f-bb6e-45e0-a52b-3087fd043b5a",
  "productndc": "86211-110",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "212628",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Mar 9, 2021"
      }
    ],
    "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": "ANDA212628",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "20260126",
  "active_numerator_strength": "3"
}

Related drugs

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