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United States · US · US:61314-144_6a98ed35-7065-4099-aefc-6d22e674ef55

Brimonidine Tartrate

Orange BookUNIISPLATC S01GA07

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

Identification

ManufacturerSandoz Inc
CountryUS (United States)
ATC codeS01GA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6131414405
    1 BOTTLE in 1 CARTON (61314-144-05) / 5 mL in 1 BOTTLE
  • ndc11
    6131414410
    1 BOTTLE in 1 CARTON (61314-144-10) / 10 mL in 1 BOTTLE
  • ndc11
    6131414415
    1 BOTTLE in 1 CARTON (61314-144-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
N021764
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": "61314-144_6a98ed35-7065-4099-aefc-6d22e674ef55",
  "productndc": "61314-144",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "021764",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AT",
        "strength": "0.15%",
        "product_no": "001",
        "approval_date": "May 22, 2006"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE",
  "proprietary_name": "Brimonidine Tartrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA021764",
  "marketing_category": "NDA",
  "nonproprietary_name": "Brimonidine Tartrate",
  "start_marketing_date": "20101002",
  "active_numerator_strength": "1.5"
}

Related drugs

Other records sharing ATC code S01GA07.

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