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United States · US · US:24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f

Tobramycin and Dexamethasone

Orange BookUNIISPLATC A01AC

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeA01AC
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420829505
    1 BOTTLE, DROPPER in 1 CARTON (24208-295-05) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420829510
    1 BOTTLE, DROPPER in 1 CARTON (24208-295-10) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    2420829525
    1 BOTTLE, DROPPER in 1 CARTON (24208-295-25) / 2.5 mL in 1 BOTTLE, DROPPER

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": "24208-295_8ef3520d-ac67-4e2d-b0a6-f876e4d1d89f",
  "productndc": "24208-295",
  "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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