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United States · US · US:39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2

Tobramycin

In shortageOrange BookUNIISPLATC J01GB01

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

Identification

ManufacturerXGen Pharmaceuticals DJB, Inc.
CountryUS (United States)
ATC codeJ01GB01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    3982204121
    1 VIAL in 1 CARTON (39822-0412-1) / 30 mL in 1 VIAL
  • ndc11
    3982204126
    6 VIAL in 1 CARTON (39822-0412-6) / 30 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)
HJT0RXD7JK
TOBRAMYCIN SULFATE
RxCUI 7276
Orange Book
A065013
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": "39822-0412_40a90656-9bc2-494b-e063-6294a90a04f2",
  "productndc": "39822-0412",
  "dosage_form": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION",
  "orange_book": {
    "appl_no": "065013",
    "products": [
      {
        "rs": true,
        "rld": false,
        "te_code": "AP",
        "strength": "EQ 1.2GM BASE/VIAL",
        "product_no": "001",
        "approval_date": "Aug 17, 2001"
      }
    ],
    "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": "ANDA065013",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin",
  "start_marketing_date": "20010817",
  "active_numerator_strength": "1.2"
}

Related drugs

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