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United States · US · US:62332-749_31b081e9-14ff-4b24-a21f-14ab41d8c0f8

Brimonidine Tartrate

Orange BookUNIISPLATC S01GA07

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

Identification

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

Packs · 3

  • ndc11
    6233274905
    1 BOTTLE in 1 CARTON (62332-749-05) / 5 mL in 1 BOTTLE
  • ndc11
    6233274910
    1 BOTTLE in 1 CARTON (62332-749-10) / 10 mL in 1 BOTTLE
  • ndc11
    6233274915
    1 BOTTLE in 1 CARTON (62332-749-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A216909
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": "62332-749_31b081e9-14ff-4b24-a21f-14ab41d8c0f8",
  "productndc": "62332-749",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "216909",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.1%",
        "product_no": "001",
        "approval_date": "Aug 1, 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": "ANDA216909",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine Tartrate",
  "start_marketing_date": "20230801",
  "active_numerator_strength": "1"
}

Related drugs

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