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United States · US · US:60505-0583_69038a16-abb9-042d-c9ac-f8727040607f

Bimatoprost

Orange BookUNIISPLATC S01EE03

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

Identification

ManufacturerApotex Corp.
CountryUS (United States)
ATC codeS01EE03
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    6050505831
    1 BOTTLE, DROPPER in 1 CARTON (60505-0583-1) / 5 mL in 1 BOTTLE, DROPPER
  • ndc11
    6050505834
    1 BOTTLE, DROPPER in 1 CARTON (60505-0583-4) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
QXS94885MZ
BIMATOPROST
RxCUI 283810
Orange Book
A090449
AT
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": "60505-0583_69038a16-abb9-042d-c9ac-f8727040607f",
  "productndc": "60505-0583",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "090449",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AT",
        "strength": "0.03%",
        "product_no": "001",
        "approval_date": "Jul 20, 2015"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "BIMATOPROST",
  "proprietary_name": "Bimatoprost",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA090449",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Bimatoprost",
  "start_marketing_date": "20181008",
  "active_numerator_strength": ".3"
}

Related drugs

Other records sharing ATC code S01EE03.

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