FDA.reportPublic FDA data

NDC 51754-1007-03 - ELCYS

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
51754-1007
Requested NDC
51754-1007-03
Package NDCs from labels
51754-1007-1, 51754-1007-3, 51754-1007-03
Manufacturer
Exela Pharma Sciences, LLC
Effective date
2024-02-01
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
ELCYS - Exela Pharma Sciences, LLCExela Pharma Sciences, LLC2024-02-01HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51754-1007-1ELCYS10 mL in 1 VIALINJECTION, SOLUTION103
51754-1007-3ELCYS100 mL in 1 CARTONINJECTION, SOLUTION1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51754-1007ELCYS (CYSTEINE HYDROCHLORIDE) INJECTION, SOLUTION [EXELA PHARMA SCIENCES, LLC]3Current NDC, Legacy NDC, 2 package rows20240202_e7652275-1c53-490c-82ad-e63867df5788.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51754-1007-1ML - Milliliter51754-1007951ca963-7fe8-481f-ad38-b3038f788d3612019-06-19
51754-1007-3ML - Milliliter51754-10070741f59d-d132-4bdb-bb10-82862f0e6e3912019-06-19

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 ยท 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TrophAmineISOLEUCINE, LEUCINE, LYSINE ACETATE, METHIONINE, PHENYLALANINE, THREONINE, TRYPTOPHAN, VALINE, CYSTEINE HYDROCHLORIDE, HISTIDINE, TYROSINE, N-ACETYL-TYROSINE, ALANINE, ARGININE, PROLINE, SERINE, GLYCINE, ASPARTIC ACID, GLUTAMIC ACID, AND TAURINEB. Braun Medical Inc.cb6d23ff-3ec5-445a-acbe-f88fd57949bf2026-08-19Warnings, Adverse reactionsExact identifier
unii: ZT934N0X4W
ELCYSCYSTEINE HYDROCHLORIDEExela Pharma Sciences, LLC52317b38-b2e6-4a1c-b5b0-43cada0d205e2026-04-09Warnings, Adverse reactionsExact identifier
application number: NDA210660
unii: ZT934N0X4W
ELCYSCYSTEINE HYDROCHLORIDEExela Pharma Sciences, LLCe7652275-1c53-490c-82ad-e63867df57882024-02-01Warnings, Adverse reactionsExact identifier
application number: NDA210660
ndc (package): 51754-1007-3
ndc (package): 51754-1007-1
ndc (product): 51754-1007
ndc11 (package): 51754100703
rxcui: 2169281
rxcui: 1667993
spl id: 04b033f6-7334-4aed-930f-beb3c349f193
spl set id: e7652275-1c53-490c-82ad-e63867df5788
unii: ZT934N0X4W
Premasol - sulfite-free (Amino Acid)LEUCINE, LYSINE, ISOLEUCINE, VALINE, HISTIDINE, PHENYLALANINE, THREONINE, METHIONINE, TRYPTOPHAN, TYROSINE, N-ACETYL-TYROSINE, ARGININE, PROLINE, ALANINE, GLUTAMIC ACIDE, SERINE, GLYCINE, ASPARTIC ACID, TAURINE, CYSTEINE HYDROCHLORIDEBaxter Healthcare Company9afdcc3e-0d06-47f4-86ca-40da48b2b02b2022-08-04Boxed warning, Warnings, Adverse reactionsExact identifier
unii: ZT934N0X4W
CYSTEINE HYDROCHLORIDECYSTEINE HYDROCHLORIDEBaxter Healthcare Corporationcbf70fc3-14b3-4c17-8de8-acba1e12ac952022-04-29Warnings, Adverse reactionsExact identifier
rxcui: 1667993
unii: ZT934N0X4W

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.