elcys

Generic: cysteine hydrochloride

Labeler: exela pharma sciences, llc
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name elcys
Generic Name cysteine hydrochloride
Labeler exela pharma sciences, llc
Dosage Form INJECTION, SOLUTION
Routes
INTRAVENOUS
Active Ingredients

cysteine hydrochloride 50 mg/mL

Manufacturer
Exela Pharma Sciences, LLC

Identifiers & Regulatory

Product NDC 51754-1008
Product ID 51754-1008_fb28ebd9-59b3-43ca-9828-b438b879bfa6
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA210660
Listing Expiration 2026-12-31
Marketing Start 2023-12-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 517541008
Hyphenated Format 51754-1008

Supplemental Identifiers

RxCUI
1486165 2671585
UNII
ZT934N0X4W

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name elcys (source: ndc)
Generic Name cysteine hydrochloride (source: ndc)
Application Number NDA210660 (source: ndc)
Routes
INTRAVENOUS
source: ndc

Resolved Composition

Strengths
  • 50 mg/mL
source: ndc
Packaging
  • 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL
source: ndc

Packages (1)

51754-1008-4 25 VIAL in 1 CARTON (51754-1008-4) / 50 mL in 1 VIAL

Ingredients (1)

cysteine hydrochloride (50 mg/mL)

Linked Drug Pages (1)

ELCYS ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["INTRAVENOUS"], "spl_id": "fb28ebd9-59b3-43ca-9828-b438b879bfa6", "openfda": {"unii": ["ZT934N0X4W"], "rxcui": ["1486165", "2671585"], "spl_set_id": ["9a52ae2f-1cea-4ad5-a074-66bbf06578d3"], "manufacturer_name": ["Exela Pharma Sciences, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "25 VIAL in 1 CARTON (51754-1008-4)  / 50 mL in 1 VIAL", "package_ndc": "51754-1008-4", "marketing_start_date": "20240101"}], "brand_name": "ELCYS", "product_id": "51754-1008_fb28ebd9-59b3-43ca-9828-b438b879bfa6", "dosage_form": "INJECTION, SOLUTION", "product_ndc": "51754-1008", "generic_name": "Cysteine Hydrochloride", "labeler_name": "Exela Pharma Sciences, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "ELCYS", "active_ingredients": [{"name": "CYSTEINE HYDROCHLORIDE", "strength": "50 mg/mL"}], "application_number": "NDA210660", "marketing_category": "NDA", "marketing_start_date": "20231212", "listing_expiration_date": "20261231"}