CEQUA

Orange BookUNIISPLATC S01XA18

Last synced from FDA National Drug Code directory (United States) on June 3, 2026

Identification

ManufacturerSun Pharmaceutical Industries, Inc.

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
4733550797
1 POUCH in 1 BOX (47335-507-97) / 10 VIAL, SINGLE-DOSE in 1 POUCH / .25 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

N210913

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "83HN0GTJ6D",
    "rxcui": "3008",
    "inchikey": "PMATZTZNYRCHOR-CGLBZJNRSA-N",
    "display_name": "CYCLOSPORINE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "OPHTHALMIC; TOPICAL",
  "spl_meta": {
    "48c3d8a3-4289-4b52-9189-58b48596095c": {
      "match": "brand_token",
      "title": "CEQUA (CYCLOSPORINE) SOLUTION/ DROPS [SUN PHARMACEUTICAL INDUSTRIES, INC.]",
      "spl_version": "12",
      "published_date": "2025-03-10"
    }
  },
  "productid": "47335-507_9db609da-42a0-42b1-87f5-020261a871ad",
  "productndc": "47335-507",
  "dosage_form": "SOLUTION/ DROPS",
  "orange_book": {
    "appl_no": "210913",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.09%",
        "product_no": "001",
        "approval_date": "Aug 14, 2018"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "CEQUA",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA210913",
  "marketing_category": "NDA",
  "nonproprietary_name": "cyclosporine",
  "start_marketing_date": "20180815",
  "active_numerator_strength": ".0009"
}

Related drugs

Other records sharing ATC code S01XA18.

Access this data programmatically

Query CEQUA 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.

Get a free API key Read the API docs