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United States · US · US:24208-503_253b0a9d-16fe-2eb1-e063-6294a90ac5e0

LOTEMAX

Orange BookUNIISPLATC S01BA14

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

Identification

ManufacturerBausch & Lomb Incorporated
CountryUS (United States)
ATC codeS01BA14
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    2420850307
    1 BOTTLE in 1 CARTON (24208-503-07) / 5 g in 1 BOTTLE
  • ndc11
    2420850348
    1 BOTTLE in 1 CARTON (24208-503-48) / .5 g in 1 BOTTLE
  • ndc11
    2420850396
    1 BOTTLE in 1 CARTON (24208-503-96) / 5 g in 1 BOTTLE

Annotations

UNII (FDA Substance ID)
YEH1EZ96K6
LOTEPREDNOL ETABONATE
RxCUI 52177
Orange Book
N202872
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": {
    "6f9477b5-699f-4d3b-b9a6-0cc238266237": {
      "match": "brand_token",
      "title": "LOTEMAX SM (LOTEPREDNOL ETABONATE) GEL [BAUSCH & LOMB INCORPORATED]",
      "spl_version": "5",
      "published_date": "2026-04-02"
    }
  },
  "productid": "24208-503_253b0a9d-16fe-2eb1-e063-6294a90ac5e0",
  "productndc": "24208-503",
  "dosage_form": "GEL",
  "orange_book": {
    "appl_no": "202872",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": "AB",
        "strength": "0.5%",
        "product_no": "001",
        "approval_date": "Sep 28, 2012"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LOTEPREDNOL ETABONATE",
  "proprietary_name": "LOTEMAX",
  "active_ingred_unit": "mg/g",
  "application_number": "NDA202872",
  "marketing_category": "NDA",
  "nonproprietary_name": "loteprednol etabonate",
  "start_marketing_date": "20121012",
  "active_numerator_strength": "5"
}

Related drugs

Other records sharing ATC code S01BA14.

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