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United States · US · US:68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279

Tobramycin and Dexamethasone

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerNuCare Pharmaceuticals,Inc.
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6807142035
    5 mL in 1 BOX (68071-4203-5)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A064134
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "7S5I7G3JQL",
    "rxcui": "3264",
    "inchikey": "UREBDLICKHMUKA-CXSFZGCWSA-N",
    "display_name": "DEXAMETHASONE",
    "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": "68071-4203_1a3b96b0-10ad-9bb1-e063-6294a90ab279",
  "productndc": "68071-4203",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "064134",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%;0.3%",
        "product_no": "001",
        "approval_date": "Oct 27, 1999"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "DEXAMETHASONE; TOBRAMYCIN",
  "proprietary_name": "Tobramycin and Dexamethasone",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA064134",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Tobramycin and Dexamethasone",
  "start_marketing_date": "19991027",
  "active_numerator_strength": "1; 3"
}

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