NDC 76014-006

Nouress

Cysteine Hydrochloride

Nouress is a Intravenous Injection in the Human Prescription Drug category. It is labeled and distributed by Avadel Legacy Pharmaceuticals, Llc. The primary component is Cysteine Hydrochloride.

• Product ID: 76014-006_c52947e7-f655-4f78-844c-5b24edaa5fce
• NDC: 76014-006
• Product Type: Human Prescription Drug
• Proprietary Name: Nouress
• Generic Name: Cysteine Hydrochloride
• Dosage Form: Injection
• Route of Administration: INTRAVENOUS
• Marketing Start Date: 2020-04-01
• Marketing Category: NDA / NDA
• Application Number: NDA212535
• Labeler Name: Avadel Legacy Pharmaceuticals, LLC
• Substance Name: CYSTEINE HYDROCHLORIDE
• Active Ingredient Strength: 35 mg/mL
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 76014-006-05

5 VIAL, SINGLE-USE in 1 CARTON (76014-006-05) > 10 mL in 1 VIAL, SINGLE-USE (76014-006-33)

• Marketing Start Date: 2020-04-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 76014-006-05 [76014000605]

Nouress INJECTION

• Marketing Category: NDA
• Application Number: NDA212535
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-01

NDC 76014-006-33 [76014000633]

Nouress INJECTION

• Marketing Category: NDA
• Application Number: NDA212535
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2020-04-01

Drug Details

Active Ingredients

Ingredient	Strength
CYSTEINE HYDROCHLORIDE	34.5 mg/mL

OpenFDA Data

• SPL SET ID: 627cc059-4124-49b3-a3d3-2eb3ed918bc7
• Manufacturer:
  • Avadel Legacy Pharmaceuticals, LLC
• UNII:
  • ZT934N0X4W
• RxNorm Concept Unique ID - RxCUI:
  • 2286589
  • 1667993
• UPC Code:
  • 0376014006056

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

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