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United States · US · US:82667-021_494dc96c-0519-0b10-e063-6294a90ae904

BYQLOVI

Orange BookUNIISPLATC D07AD01

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

Identification

ManufacturerHarrow Eye, LLC
CountryUS (United States)
ATC codeD07AD01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    8266702100
    1 BOTTLE, PLASTIC in 1 CARTON (82667-021-00) / 3.5 mL in 1 BOTTLE, PLASTIC
  • ndc11
    8266702105
    1 BOTTLE, PLASTIC in 1 CARTON (82667-021-05) / 3.5 mL in 1 BOTTLE, PLASTIC

Annotations

UNII (FDA Substance ID)
779619577M
CLOBETASOL PROPIONATE
RxCUI 21245
Orange Book
N218158
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "779619577M",
    "rxcui": "21245",
    "inchikey": "CBGUOGMQLZIXBE-XGQKBEPLSA-N",
    "display_name": "CLOBETASOL PROPIONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "31ca5a0f-812e-491d-aa00-d8ed424ba322": {
      "match": "brand_token",
      "title": "BYQLOVI (CLOBETASOL PROPIONATE) FOR SUSPENSION [HARROW EYE, LLC]",
      "spl_version": "3",
      "published_date": "2026-01-28"
    }
  },
  "productid": "82667-021_494dc96c-0519-0b10-e063-6294a90ae904",
  "productndc": "82667-021",
  "dosage_form": "FOR SUSPENSION",
  "orange_book": {
    "appl_no": "218158",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Mar 4, 2024"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CLOBETASOL PROPIONATE",
  "proprietary_name": "BYQLOVI",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA218158",
  "marketing_category": "NDA",
  "nonproprietary_name": "clobetasol propionate",
  "start_marketing_date": "20240304",
  "active_numerator_strength": ".5"
}

Related drugs

Other records sharing ATC code D07AD01.

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