NDC 0378-9040

Cystagon

Cysteamine Bitartrate

Cystagon is a Oral Capsule in the Human Prescription Drug category. It is labeled and distributed by Mylan Pharmaceuticals Inc.. The primary component is Cysteamine Bitartrate.

• Product ID: 0378-9040_263f8238-b6bd-42fa-b339-f27ede4026e2
• NDC: 0378-9040
• Product Type: Human Prescription Drug
• Proprietary Name: Cystagon
• Generic Name: Cysteamine Bitartrate
• Dosage Form: Capsule
• Route of Administration: ORAL
• Marketing Start Date: 2005-04-11
• Marketing End Date: 2030-01-01
• Marketing Category: NDA / NDA
• Application Number: NDA020392
• Labeler Name: Mylan Pharmaceuticals Inc.
• Substance Name: CYSTEAMINE BITARTRATE
• Active Ingredient Strength: 50 mg/1
• Pharm Classes: Cystine Depleting Agent [EPC],Cystine Disulfide Reduction [MoA]
• NDC Exclude Flag: N

Packaging

NDC 0378-9040-05

500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9040-05)

• Marketing Start Date: 2005-04-11
• Marketing End Date: 2030-01-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0378-9040-01 [00378904001]

Cystagon CAPSULE

• Marketing Category: NDA
• Application Number: NDA020392
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 1994-08-15
• Marketing End Date: 2018-09-04

NDC 0378-9040-05 [00378904005]

Cystagon CAPSULE

• Marketing Category: NDA
• Application Number: NDA020392
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2005-04-11

Drug Details

Active Ingredients

Ingredient	Strength
CYSTEAMINE BITARTRATE	50 mg/1

OpenFDA Data

• SPL SET ID: f495b76d-96c6-48e5-8fa3-30a4336628eb
• Manufacturer:
  • Mylan Pharmaceuticals Inc.
• UNII:
  • QO84GZ3TST
• RxNorm Concept Unique ID - RxCUI:
  • 209788
  • 209789
  • 309637
  • 309636
• UPC Code:
  • 0303789045058

Pharmacological Class

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

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

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