Gengraf

Orange BookUNIISPLATC S01XA18

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

Identification

ManufacturerAbbVie Inc.

CountryUS (United States)

ATC codeS01XA18

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
0074310832
3 BLISTER PACK in 1 CARTON (0074-3108-32) / 10 CAPSULE in 1 BLISTER PACK

Annotations

UNII (FDA Substance ID)

83HN0GTJ6D

CYCLOSPORINE

RxCUI 3008

Orange Book

A065003

AB1AB1

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": {
    "e896cbfe-4745-4088-82a3-8dc10b75c41f": {
      "match": "brand_token",
      "title": "GENGRAF (CYCLOSPORINE) CAPSULE [ABBVIE INC.]",
      "spl_version": "1256",
      "published_date": "2026-05-21"
    }
  },
  "productid": "0074-3108_38f517b9-c5d1-479a-9117-f65ea1d479d4",
  "productndc": "0074-3108",
  "dosage_form": "CAPSULE",
  "orange_book": {
    "appl_no": "065003",
    "products": [
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "25MG",
        "product_no": "001",
        "approval_date": "May 12, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": null,
        "strength": "50MG",
        "product_no": "002",
        "approval_date": "May 12, 2000"
      },
      {
        "rs": false,
        "rld": false,
        "te_code": "AB1",
        "strength": "100MG",
        "product_no": "003",
        "approval_date": "May 12, 2000"
      }
    ],
    "appl_type": "A"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYCLOSPORINE",
  "proprietary_name": "Gengraf",
  "active_ingred_unit": "mg/1",
  "application_number": "ANDA065003",
  "marketing_category": "ANDA",
  "nonproprietary_name": "Cyclosporine",
  "start_marketing_date": "20151101",
  "active_numerator_strength": "25"
}

Related drugs

Other records sharing ATC code S01XA18.

Access this data programmatically

Query Gengraf 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