Cyclosporine

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerTeva Pharmaceuticals USA, Inc.

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0172731320
1 BOTTLE in 1 PACKAGE (0172-7313-20) / 50 mL in 1 BOTTLE

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

A065078

AB1

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": "ORAL",
  "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": "0172-7313_94a2cdae-e60e-47c4-8bca-8baac9f21b33",
  "productndc": "0172-7313",
  "dosage_form": "SOLUTION",
  "orange_book": {
    "appl_no": "065078",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG/ML",
        "product_no": "001",
        "approval_date": "Mar 25, 2005"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Cyclosporine",
  "active_ingred_unit": "mg/mL",
  "application_number": "ANDA065078",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20050329",
  "active_numerator_strength": "100"
}

Related drugs

Other records sharing ATC code S01XA18.

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