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United States · US · US:47335-317_44b8ddc0-81dc-4613-bbe8-0da960cc179c

XELPROS

Orange BookUNIISPLATC S01EE01

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

Identification

ManufacturerSun Pharmaceutical Industries, Inc.
CountryUS (United States)
ATC codeS01EE01
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 4

  • ndc11
    4733531790
    1 BOTTLE, DROPPER in 1 BOX (47335-317-90) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    4733531792
    3 BOTTLE, DROPPER in 1 BOX (47335-317-92) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    4733531794
    3 BOTTLE, DROPPER in 1 BOX (47335-317-94) / 2.5 mL in 1 BOTTLE, DROPPER
  • ndc11
    4733531798
    1 BOTTLE, DROPPER in 1 BOX (47335-317-98) / 2.5 mL in 1 BOTTLE, DROPPER

Annotations

UNII (FDA Substance ID)
6Z5B6HVF6O
LATANOPROST
RxCUI 43611
Orange Book
N206185
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "6Z5B6HVF6O",
    "rxcui": "43611",
    "inchikey": "GGXICVAJURFBLW-CEYXHVGTSA-N",
    "display_name": "LATANOPROST",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC; TOPICAL",
  "spl_meta": {
    "34ad5cf6-4df0-4104-bddd-4c7631133ded": {
      "match": "brand_token",
      "title": "XELPROS (LATANOPROST) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "11",
      "published_date": "2025-12-23"
    }
  },
  "productid": "47335-317_44b8ddc0-81dc-4613-bbe8-0da960cc179c",
  "productndc": "47335-317",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "206185",
    "products": [
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "0.005%",
        "product_no": "001",
        "approval_date": "Sep 12, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "LATANOPROST",
  "proprietary_name": "XELPROS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA206185",
  "marketing_category": "NDA",
  "nonproprietary_name": "latanoprost",
  "start_marketing_date": "20180912",
  "active_numerator_strength": ".05"
}

Related drugs

Other records sharing ATC code S01EE01.

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