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United States · US · US:51754-1008_fb28ebd9-59b3-43ca-9828-b438b879bfa6
ELCYS
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
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
- ndc11517541008425 VIAL in 1 CARTON (51754-1008-4) / 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_fb28ebd9-59b3-43ca-9828-b438b879bfa6",
"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
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