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United States · US · US:71921-185_81960280-6045-44e8-a499-6f737a92c7f2

Brimonidine Tartrate

Orange BookUNIISPLATC S01GA07

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

Identification

ManufacturerFlorida Pharmaceutical Products, LLC
CountryUS (United States)
ATC codeS01GA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7192118505
    5 mg in 1 BOTTLE, PLASTIC (71921-185-05)
  • ndc11
    7192118510
    10 mg in 1 BOTTLE, PLASTIC (71921-185-10)
  • ndc11
    7192118515
    15 mg in 1 BOTTLE, PLASTIC (71921-185-15)

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A091691
AT
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": "71921-185_81960280-6045-44e8-a499-6f737a92c7f2",
  "productndc": "71921-185",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "091691",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.2%",
        "product_no": "001",
        "approval_date": "Nov 18, 2014"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE",
  "proprietary_name": "Brimonidine Tartrate",
  "active_ingred_unit": "mg/mg",
  "application_number": "ANDA091691",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine Tartrate",
  "start_marketing_date": "20220115",
  "active_numerator_strength": "2"
}

Related drugs

Other records sharing ATC code S01GA07.

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