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United States · US · US:42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8

Brimonidine tartrate

Orange BookUNIISPLATC S01GA07

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

Identification

ManufacturerMicro Labs Limited
CountryUS (United States)
ATC codeS01GA07
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    4257141956
    1 BOTTLE, DROPPER in 1 CARTON (42571-419-56) / 10 mL in 1 BOTTLE, DROPPER
  • ndc11
    4257141957
    1 BOTTLE, DROPPER in 1 CARTON (42571-419-57) / 15 mL in 1 BOTTLE, DROPPER
  • ndc11
    4257141992
    1 BOTTLE, DROPPER in 1 CARTON (42571-419-92) / 5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A217846
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": "42571-419_3aac4288-aa47-296b-e063-6294a90a8fd8",
  "productndc": "42571-419",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "217846",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.2%",
        "product_no": "001",
        "approval_date": "Nov 22, 2023"
      }
    ],
    "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": "ANDA217846",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine tartrate",
  "start_marketing_date": "20240401",
  "active_numerator_strength": "2"
}

Related drugs

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