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United States · US · US:81469-291_ca1226b7-9c73-4105-9eea-9f60ca622f71

Bimatoprost

Orange BookUNIISPLATC S01EE03

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

Identification

ManufacturerFirst Nation Group, LLC
CountryUS (United States)
ATC codeS01EE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8146929105
    1 BOTTLE in 1 CARTON (81469-291-05) / 5 mL in 1 BOTTLE
  • ndc11
    8146929125
    1 BOTTLE in 1 CARTON (81469-291-25) / 2.5 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
QXS94885MZ
BIMATOPROST
RxCUI 283810
Orange Book
A218196
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "QXS94885MZ",
    "rxcui": "283810",
    "inchikey": "AQOKCDNYWBIDND-FTOWTWDKSA-N",
    "display_name": "BIMATOPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "6a74ad65-dd76-45c1-9bbe-4218a9978b70": {
      "match": "brand_token",
      "title": "BIMATOPROST SOLUTION/ DROPS [FIRST NATION GROUP, LLC]",
      "spl_version": "1",
      "published_date": "2026-05-01"
    }
  },
  "productid": "81469-291_ca1226b7-9c73-4105-9eea-9f60ca622f71",
  "productndc": "81469-291",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "218196",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.01%",
        "product_no": "001",
        "approval_date": "Mar 17, 2025"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BIMATOPROST",
  "proprietary_name": "Bimatoprost",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA218196",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bimatoprost",
  "start_marketing_date": "20260501",
  "active_numerator_strength": ".1"
}

Related drugs

Other records sharing ATC code S01EE03.

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