Back to search
🇺🇸

United States · US · US:70244-036_4f81be91-92e8-1205-e063-6394a90a6e82

Loteprednol Etabonate

Orange BookUNIISPLATC S01BA14

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

Identification

ManufacturerSentiss Pharmaceuticals LLC
CountryUS (United States)
ATC codeS01BA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 1

  • ndc11
    7024403601
    1 BOTTLE, DROPPER in 1 CARTON (70244-036-01) / 5 g in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
A212080
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "YEH1EZ96K6",
    "rxcui": "52177",
    "inchikey": "DMKSVUSAATWOCU-HROMYWEYSA-N",
    "display_name": "LOTEPREDNOL ETABONATE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC",
  "spl_meta": {
    "3c2e7083-6ba1-4131-a23f-462b02e5c036": {
      "match": "brand_token",
      "title": "LOTEPREDNOL ETABONATE SUSPENSION/ DROPS [AMNEAL PHARMACEUTICALS NY LLC]",
      "spl_version": "5",
      "published_date": "2026-04-28"
    }
  },
  "productid": "70244-036_4f81be91-92e8-1205-e063-6394a90a6e82",
  "productndc": "70244-036",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "212080",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Feb 10, 2021"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOTEPREDNOL ETABONATE",
  "proprietary_name": "Loteprednol Etabonate",
  "active_ingred_unit": "mg/g",
  "application_number": "ANDA212080",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Loteprednol Etabonate",
  "start_marketing_date": "20260417",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code S01BA14.

Access this data programmatically

Query Loteprednol Etabonate and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.