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United States · US · US:63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

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

Packs · 2

  • ndc11
    6318790202
    1 BOTTLE, DROPPER in 1 CARTON (63187-902-02) / 2 mL in 1 BOTTLE, DROPPER
  • ndc11
    6318790205
    1 BOTTLE, DROPPER in 1 CARTON (63187-902-05) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
VZ8RRZ51VK
TOBRAMYCIN
RxCUI 10627
Orange Book
A064096
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": "63187-902_f1b5aa19-119f-4d5a-aa8d-8f3778a48753",
  "productndc": "63187-902",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "064096",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "0.3%",
        "product_no": "001",
        "approval_date": "Jan 31, 1996"
      }
    ],
    "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": "ANDA064096",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "19960131",
  "active_numerator_strength": "3"
}

Related drugs

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