NDC 75987-100

PROCYSBI

Cysteamine Bitartrate

PROCYSBI is a Oral Capsule, Delayed Release Pellets in the Human Prescription Drug category. It is labeled and distributed by Horizon Therapeutics Usa, Inc.. The primary component is Cysteamine Bitartrate.

• Product ID: 75987-100_03837d9e-aee3-46e9-a893-b05a24397170
• NDC: 75987-100
• Product Type: Human Prescription Drug
• Proprietary Name: PROCYSBI
• Generic Name: Cysteamine Bitartrate
• Dosage Form: Capsule, Delayed Release Pellets
• Route of Administration: ORAL
• Marketing Start Date: 2013-04-30
• Marketing Category: NDA / NDA
• Application Number: NDA203389
• Labeler Name: Horizon Therapeutics USA, Inc.
• Substance Name: CYSTEAMINE BITARTRATE
• Active Ingredient Strength: 25 mg/1
• Pharm Classes: Cystine Depleting Agent [EPC], Cystine Disulfide Reduction [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 75987-100-04

60 CAPSULE, DELAYED RELEASE PELLETS in 1 BOTTLE (75987-100-04)

• Marketing Start Date: 2013-04-30
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 75987-100-04 [75987010004]

PROCYSBI CAPSULE, DELAYED RELEASE PELLETS

• Marketing Category: NDA
• Application Number: NDA203389
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2013-04-30

Drug Details

Active Ingredients

Ingredient	Strength
CYSTEAMINE BITARTRATE	25 mg/1

OpenFDA Data

• SPL SET ID: d3a3ec28-f746-463a-bb92-3bc8826db09e
• Manufacturer:
  • Horizon Pharma Inc.
• UNII:
  • QO84GZ3TST
• RxNorm Concept Unique ID - RxCUI:
  • 1421473
  • 1421467
  • 1421477
  • 1421475
• UPC Code:
  • 0375987100044
  • 0375987101089

Pharmacological Class

• Cystine Depleting Agent [EPC]
• Cystine Disulfide Reduction [MoA]

NDC Crossover Matching brand name "PROCYSBI" or generic name "Cysteamine Bitartrate"

NDC	Brand Name	Generic Name
75987-100	PROCYSBI	Cysteamine bitartrate
75987-101	PROCYSBI	Cysteamine bitartrate
75987-140	PROCYSBI	Cysteamine bitartrate
75987-145	PROCYSBI	Cysteamine bitartrate
0378-9040	Cystagon	cysteamine bitartrate
0378-9045	Cystagon	cysteamine bitartrate