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United States · US · US:0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a

SIMBRINZA

Orange BookUNIISPLATC D11AX

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeD11AX
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0065414725
    1 BOTTLE, DROPPER in 1 CARTON (0065-4147-25) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    0065414727
    1 BOTTLE, DROPPER in 1 CARTON (0065-4147-27) / 8 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
N204251
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "4S9CL2DY2H",
    "rxcui": "39171",
    "inchikey": "QZHBYNSSDLTCRG-LREBCSMRSA-N",
    "display_name": "BRIMONIDINE TARTRATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "a49c157e-6310-0011-7b7f-e26fc1820d59": {
      "match": "brand_token",
      "title": "SIMBRINZA (BRINZOLAMIDE/BRIMONIDINE TARTRATE) SUSPENSION/ DROPS [ALCON LABORATORIES, INC.]",
      "spl_version": "19",
      "published_date": "2025-03-17"
    }
  },
  "productid": "0065-4147_889225d1-6257-4b32-b9cc-5f9c459c994a",
  "productndc": "0065-4147",
  "dosage_form": "SUSPENSION/ DROPS",
  "orange_book": {
    "appl_no": "204251",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.2%;1%",
        "product_no": "001",
        "approval_date": "Apr 19, 2013"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE; BRINZOLAMIDE",
  "proprietary_name": "SIMBRINZA",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "NDA204251",
  "marketing_category": "NDA",
  "nonproprietary_name": "brinzolamide/brimonidine tartrate",
  "start_marketing_date": "20130506",
  "active_numerator_strength": "2; 10"
}

Related drugs

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