cystadane

Generic: betaine

Labeler: recordati rare diseases
NDC Directory HUMAN PRESCRIPTION DRUG NDA Inactive Finished

Drug Facts

Product Profile

Brand Name cystadane
Generic Name betaine
Labeler recordati rare diseases
Dosage Form POWDER, FOR SOLUTION
Routes
ORAL
Active Ingredients

betaine 1 g/g

Manufacturer
Recordati Rare Diseases

Identifiers & Regulatory

Product NDC 52276-400
Product ID 52276-400_e89ca7b8-3efb-4476-9c6f-49f574c30046
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category NDA
Application Number NDA020576
Listing Expiration 2026-12-31
Marketing Start 1996-10-25

Pharmacologic Class

Established (EPC)
methylating agent [epc]
Mechanism of Action
methylating activity [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 52276400
Hyphenated Format 52276-400

Supplemental Identifiers

RxCUI
404539 562847
UNII
3SCV180C9W
NUI
N0000175804 N0000175805

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name cystadane (source: ndc)
Generic Name betaine (source: ndc)
Application Number NDA020576 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 1 g/g
source: ndc
Packaging
  • 180 g in 1 BOTTLE (52276-400-01)
source: ndc

Packages (1)

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

Ingredients (1)

betaine (1 g/g)

Linked Drug Pages (1)

Cystadane ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "e89ca7b8-3efb-4476-9c6f-49f574c30046", "openfda": {"nui": ["N0000175804", "N0000175805"], "unii": ["3SCV180C9W"], "rxcui": ["404539", "562847"], "spl_set_id": ["31a684d0-cd98-4e46-b43a-ccbd17c41559"], "pharm_class_epc": ["Methylating Agent [EPC]"], "pharm_class_moa": ["Methylating Activity [MoA]"], "manufacturer_name": ["Recordati Rare Diseases"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "180 g in 1 BOTTLE (52276-400-01)", "package_ndc": "52276-400-01", "marketing_start_date": "20170413"}], "brand_name": "Cystadane", "product_id": "52276-400_e89ca7b8-3efb-4476-9c6f-49f574c30046", "dosage_form": "POWDER, FOR SOLUTION", "pharm_class": ["Methylating Activity [MoA]", "Methylating Agent [EPC]"], "product_ndc": "52276-400", "generic_name": "betaine", "labeler_name": "Recordati Rare Diseases", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Cystadane", "active_ingredients": [{"name": "BETAINE", "strength": "1 g/g"}], "application_number": "NDA020576", "marketing_category": "NDA", "marketing_start_date": "19961025", "listing_expiration_date": "20261231"}