NDC 51754-1007

ELCYS

Cysteine Hydrochloride

ELCYS is a Intravenous Injection, Solution in the Human Prescription Drug category. It is labeled and distributed by Exela Pharma Sciences, Llc. The primary component is Cysteine Hydrochloride.

• Product ID: 51754-1007_3f3dc2d1-9383-4c95-b97a-3e25c588d8a4
• NDC: 51754-1007
• Product Type: Human Prescription Drug
• Proprietary Name: ELCYS
• Generic Name: Cysteine Hydrochloride
• Dosage Form: Injection, Solution
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2019-05-28
• Marketing Category: NDA / NDA
• Application Number: NDA210660
• Labeler Name: Exela Pharma Sciences, LLC
• Substance Name: CYSTEINE HYDROCHLORIDE
• Active Ingredient Strength: 10 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 51754-1007-1

10 mL in 1 VIAL (51754-1007-1)

• Marketing Start Date: 2019-05-28
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 51754-1007-1 [51754100701]

ELCYS INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA210660
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-05-28

NDC 51754-1007-3 [51754100703]

ELCYS INJECTION, SOLUTION

• Marketing Category: NDA
• Application Number: NDA210660
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: ML
• Marketing Start Date: 2019-05-28

Drug Details

Active Ingredients

Ingredient	Strength
CYSTEINE HYDROCHLORIDE	10 mg/mL

OpenFDA Data

• SPL SET ID: e7652275-1c53-490c-82ad-e63867df5788
• Manufacturer:
  • Exela Pharma Sciences, LLC
• UNII:
  • ZT934N0X4W

NDC Crossover Matching brand name "ELCYS" or generic name "Cysteine Hydrochloride"

NDC	Brand Name	Generic Name
51754-1007	ELCYS	Cysteine Hydrochloride
0338-9645	CYSTEINE HYDROCHLORIDE	cysteine hydrochloride
76014-006	Nouress	cysteine hydrochloride