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United States · US · US:63629-9572_d236928f-4540-4c57-9611-bec124946957

TOBRAMYCIN AND DEXAMETHASONE

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerBryant Ranch Prepack
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    6362995721
    10 mL in 1 BOTTLE, PLASTIC (63629-9572-1)

Annotations

UNII (FDA Substance ID)
7S5I7G3JQL
DEXAMETHASONE
RxCUI 3264
Orange Book
A212715
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": "63629-9572_d236928f-4540-4c57-9611-bec124946957",
  "productndc": "63629-9572",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "212715",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%;0.3%",
        "product_no": "001",
        "approval_date": "Feb 11, 2022"
      }
    ],
    "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": "ANDA212715",
  "marketing_category": "ANDA",
  "nonproprietary_name": "tobramycin and dexamethasone",
  "start_marketing_date": "20220317",
  "active_numerator_strength": "1; 3"
}

Related drugs

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