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United States · US · US:52276-400_3a4fdd66-b72b-4aa3-94bb-bac8af98b150
Cystadane
Orange BookUNIISPLATC A16AA06
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRecordati Rare Diseases
CountryUS (United States)
ATC codeA16AA06
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc115227640001180 g in 1 BOTTLE (52276-400-01)
Annotations
UNII (FDA Substance ID)
3SCV180C9W
BETAINE
RxCUI 350374
Orange Book
N020576
AB
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "3SCV180C9W",
"rxcui": "350374",
"inchikey": "KWIUHFFTVRNATP-UHFFFAOYSA-N",
"display_name": "BETAINE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"31a684d0-cd98-4e46-b43a-ccbd17c41559": {
"match": "brand_token",
"title": "CYSTADANE (BETAINE) POWDER, FOR SOLUTION [RECORDATI RARE DISEASES]",
"spl_version": "7",
"published_date": "2026-04-27"
}
},
"productid": "52276-400_3a4fdd66-b72b-4aa3-94bb-bac8af98b150",
"productndc": "52276-400",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "020576",
"products": [
{
"rs": true,
"rld": true,
"te_code": "AB",
"strength": "1GM/SCOOPFUL",
"product_no": "001",
"approval_date": "Oct 25, 1996"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "BETAINE",
"proprietary_name": "Cystadane",
"active_ingred_unit": "g/g",
"application_number": "NDA020576",
"marketing_category": "NDA",
"nonproprietary_name": "betaine",
"start_marketing_date": "19961025",
"active_numerator_strength": "1"
}Related drugs
Other records sharing ATC code A16AA06.
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