NDC 66621-4000

Cystadane

Betaine

Cystadane is a Oral Powder, For Solution in the Human Prescription Drug category. It is labeled and distributed by Rare Disease Therapeutics, Inc.. The primary component is Betaine.

• Product ID: 66621-4000_d797121e-e13a-41b8-b7d7-e104ba26077c
• NDC: 66621-4000
• Product Type: Human Prescription Drug
• Proprietary Name: Cystadane
• Generic Name: Betaine
• Dosage Form: Powder, For Solution
• Route of Administration: ORAL
• Marketing Start Date: 1996-10-25
• Marketing Category: NDA / NDA
• Application Number: NDA020576
• Labeler Name: Rare Disease Therapeutics, Inc.
• Substance Name: BETAINE
• Active Ingredient Strength: 6 g/1
• Pharm Classes: Methylating Activity [MoA],Methylating Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2019-12-31

Packaging

NDC 66621-4000-1

180 POWDER, FOR SOLUTION in 1 BOTTLE (66621-4000-1)

• Marketing Start Date: 1996-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 66621-4000-1 [66621400001]

Cystadane POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020576
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 1996-10-25
• Inactivation Date: 2020-01-31

Drug Details

Active Ingredients

Ingredient	Strength
BETAINE	6 g/1

OpenFDA Data

• SPL SET ID: 84f7c21f-d0af-4ae6-9cd5-d5af96ade329
• Manufacturer:
  • Rare Disease Therapeutics, Inc.
• UNII:
  • 3SCV180C9W
• RxNorm Concept Unique ID - RxCUI:
  • 404539
  • 562847
• UPC Code:
  • 0366621400019

Pharmacological Class

• Methylating Activity [MoA]
• Methylating Agent [EPC]

NDC Crossover Matching brand name "Cystadane" or generic name "Betaine"

NDC	Brand Name	Generic Name
52276-400	Cystadane	betaine
52276-401	Cystadane	betaine
64811-400	Cystadane	BETAINE
66621-4000	Cystadane	betaine
70993-0005	ATONO2 Oxygen Baby	Betaine
0713-0352	Betaine	Betaine
55792-002	Betaine Anhydrous For Oral Solution	betaine
83071-020	Dr.Jucre Rebirth Activating Toner	Betaine