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United States · US · US:0065-9307_02b53b1c-e4e2-40eb-9283-073996bbee67

Inveltys

Orange BookUNIISPLATC S01BA14

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

Identification

ManufacturerAlcon Laboratories, Inc.
CountryUS (United States)
ATC codeS01BA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0065930704
    1 BOTTLE, DROPPER in 1 CARTON (0065-9307-04) / 2.8 mL in 1 BOTTLE, DROPPER
  • ndc11
    0065930705
    1 BOTTLE, DROPPER in 1 CARTON (0065-9307-05) / 2.8 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N210565
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": {
    "bdd18e84-79b3-4c8b-a07f-eb06cf52e68c": {
      "match": "brand_token",
      "title": "INVELTYS (LOTEPREDNOL ETABONATE) SUSPENSION [ALCON LABORATORIES, INC.]",
      "spl_version": "1",
      "published_date": "2026-04-30"
    }
  },
  "productid": "0065-9307_02b53b1c-e4e2-40eb-9283-073996bbee67",
  "productndc": "0065-9307",
  "dosage_form": "SUSPENSION",
  "orange_book": {
    "appl_no": "210565",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "1%",
        "product_no": "001",
        "approval_date": "Aug 22, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOTEPREDNOL ETABONATE",
  "proprietary_name": "Inveltys",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA210565",
  "marketing_category": "NDA",
  "nonproprietary_name": "Loteprednol Etabonate",
  "start_marketing_date": "20260416",
  "active_numerator_strength": "10"
}

Related drugs

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