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United States · US · US:60505-0577_cffa6894-6b96-1f60-19c5-09aca95c791e

Brimonidine Tartrate

Orange BookUNIISPLATC S01GA07

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeS01GA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    6050505771
    1 BOTTLE, DROPPER in 1 CARTON (60505-0577-1) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    6050505772
    1 BOTTLE, DROPPER in 1 CARTON (60505-0577-2) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    6050505773
    1 BOTTLE, DROPPER in 1 CARTON (60505-0577-3) / 15 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A078480
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": "60505-0577_cffa6894-6b96-1f60-19c5-09aca95c791e",
  "productndc": "60505-0577",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "078480",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Dec 21, 2022"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE",
  "proprietary_name": "Brimonidine Tartrate",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA078480",
  "marketing_category": "ANDA",
  "nonproprietary_name": "brimonidine tartrate",
  "start_marketing_date": "20230902",
  "active_numerator_strength": "1"
}

Related drugs

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