ELCYS

Orange BookUNIISPL

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

Identification

ManufacturerExela Pharma Sciences, LLC

CountryUS (United States)

ATC code—

Dispensing—

ReimbursedNo

SourceFDA National Drug Code directory (United States)

Last synced6/3/2026

Packs · 1

ndc11
5175410081
1 VIAL in 1 CARTON (51754-1008-1) / 50 mL in 1 VIAL

Annotations

UNII (FDA Substance ID)

ZT934N0X4W

CYSTEINE HYDROCHLORIDE

RxCUI 221086

Orange Book

N210660

DailyMed SPL labels

1 version tracked

Raw payload (JSON)

{
  "unii": {
    "unii": "ZT934N0X4W",
    "rxcui": "221086",
    "inchikey": "QIJRTFXNRTXDIP-JIZZDEOASA-N",
    "display_name": "CYSTEINE HYDROCHLORIDE",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "INTRAVENOUS",
  "spl_meta": {
    "52317b38-b2e6-4a1c-b5b0-43cada0d205e": {
      "match": "brand_token",
      "title": "ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]",
      "spl_version": "3",
      "published_date": "2026-04-10"
    }
  },
  "productid": "51754-1008_5e7be8d4-66c2-4bab-849f-46eaac9996cb",
  "productndc": "51754-1008",
  "dosage_form": "INJECTION, SOLUTION",
  "orange_book": {
    "appl_no": "210660",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "500MG/10ML (50MG/ML)",
        "product_no": "001",
        "approval_date": "Apr 16, 2019"
      },
      {
        "rs": false,
        "rld": true,
        "te_code": null,
        "strength": "2500MG/50ML (50MG/ML)",
        "product_no": "002",
        "approval_date": "Dec 4, 2023"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CYSTEINE HYDROCHLORIDE",
  "proprietary_name": "ELCYS",
  "active_ingred_unit": "mg/mL",
  "application_number": "NDA210660",
  "marketing_category": "NDA",
  "nonproprietary_name": "Cysteine Hydrochloride",
  "start_marketing_date": "20231212",
  "active_numerator_strength": "50"
}

Access this data programmatically

Query ELCYS 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