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United States · US · US:0781-7186_0b872a04-2f4a-4f0b-9fd9-d5151b36217e

Brimonidine Tartrate and Timolol Maleate

Orange BookUNIISPLATC D11AX

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

Identification

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

Packs · 3

  • ndc11
    0781718670
    1 BOTTLE in 1 CARTON (0781-7186-70) / 10 mL in 1 BOTTLE
  • ndc11
    0781718675
    1 BOTTLE in 1 CARTON (0781-7186-75) / 5 mL in 1 BOTTLE
  • ndc11
    0781718685
    1 BOTTLE in 1 CARTON (0781-7186-85) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A091087
AB
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": {
    "f6666d85-f810-4869-993d-e8ae35b4517f": {
      "match": "brand_token",
      "title": "BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION SOLUTION/ DROPS [LIFESTAR PHARMA LLC]",
      "spl_version": "5",
      "published_date": "2026-06-02"
    }
  },
  "productid": "0781-7186_0b872a04-2f4a-4f0b-9fd9-d5151b36217e",
  "productndc": "0781-7186",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "091087",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.2%;EQ 0.5% BASE",
        "product_no": "001",
        "approval_date": "Apr 4, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE; TIMOLOL MALEATE",
  "proprietary_name": "Brimonidine Tartrate and Timolol Maleate",
  "active_ingred_unit": "mg/mL; mg/mL",
  "application_number": "ANDA091087",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine Tartrate and Timolol Maleate",
  "start_marketing_date": "20220413",
  "active_numerator_strength": "2; 5"
}

Related drugs

Other records sharing ATC code D11AX.

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