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United States · US · US:46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820b

Brimonidine Tartrate ophthalmic solution, 0.15%

Orange BookUNIISPLATC S01GA07

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

Identification

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

Packs · 3

  • ndc11
    4670866105
    1 BOTTLE in 1 CARTON (46708-661-05) / 5 mL in 1 BOTTLE
  • ndc11
    4670866110
    1 BOTTLE in 1 CARTON (46708-661-10) / 10 mL in 1 BOTTLE
  • ndc11
    4670866115
    1 BOTTLE in 1 CARTON (46708-661-15) / 15 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
4S9CL2DY2H
BRIMONIDINE TARTRATE
RxCUI 39171
Orange Book
A215225
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": "46708-661_e1ea003e-3dd9-41c7-9119-d1f209b9820b",
  "productndc": "46708-661",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "215225",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.15%",
        "product_no": "001",
        "approval_date": "Mar 29, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BRIMONIDINE TARTRATE",
  "proprietary_name": "Brimonidine Tartrate ophthalmic solution, 0.15%",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA215225",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Brimonidine Tartrate ophthalmic solution, 0.15%",
  "start_marketing_date": "20230329",
  "active_numerator_strength": "1.5"
}

Related drugs

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