NDC 52276-400

Cystadane

Betaine

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

• Product ID: 52276-400_1f286147-1f5c-4f83-984e-af1298b8712c
• NDC: 52276-400
• 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: Recordati Rare Diseases
• Substance Name: BETAINE
• Active Ingredient Strength: 1 g/g
• Pharm Classes: Methylating Activity [MoA], Methylating Agent [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2024-12-31

Packaging

NDC 52276-400-01

180 g in 1 BOTTLE (52276-400-01)

• Marketing Start Date: 2017-04-13
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 52276-400-01 [52276040001]

Cystadane POWDER, FOR SOLUTION

• Marketing Category: NDA
• Application Number: NDA020576
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: GM
• Marketing Start Date: 2017-04-13

Drug Details

Active Ingredients

Ingredient	Strength
BETAINE	1 g/g

OpenFDA Data

• SPL SET ID: 31a684d0-cd98-4e46-b43a-ccbd17c41559
• Manufacturer:
  • Orphan Europe SARL
• UNII:
  • 3SCV180C9W
• RxNorm Concept Unique ID - RxCUI:
  • 404539
  • 562847

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