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United States · US · US:0480-4076_0dc3c832-fe01-4913-ba52-47cca4c890b4

Cyclosporine

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerTeva Pharmaceuticals, Inc.
CountryUS (United States)
ATC codeS01XA18
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 2

  • ndc11
    0480407630
    6 POUCH in 1 CARTON (0480-4076-30) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE
  • ndc11
    0480407660
    12 POUCH in 1 CARTON (0480-4076-60) / 5 VIAL, SINGLE-DOSE in 1 POUCH / .4 mL in 1 VIAL, SINGLE-DOSE

Annotations

UNII (FDA Substance ID)
83HN0GTJ6D
CYCLOSPORINE
RxCUI 3008
Orange Book
A203880
AB
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",
  "spl_meta": {
    "f7e4a2f0-ea2a-449b-bc6d-a6ea3d47b850": {
      "match": "brand_token",
      "title": "CYCLOSPORINE EMULSION [UPSHER-SMITH LABORATORIES, LLC]",
      "spl_version": "2",
      "published_date": "2026-05-25"
    }
  },
  "productid": "0480-4076_0dc3c832-fe01-4913-ba52-47cca4c890b4",
  "productndc": "0480-4076",
  "dosage_form": "EMULSION",
  "orange_book": {
    "appl_no": "203880",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB",
        "strength": "0.05%",
        "product_no": "001",
        "approval_date": "Dec 14, 2023"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Cyclosporine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA203880",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20251028",
  "active_numerator_strength": ".5"
}

Related drugs

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