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United States · US · US:0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b
Cystagon
Orange BookUNIISPLATC A16AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerMylan Pharmaceuticals Inc.
CountryUS (United States)
ATC codeA16AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc110378904505500 CAPSULE in 1 BOTTLE, PLASTIC (0378-9045-05)
Annotations
UNII (FDA Substance ID)
QO84GZ3TST
CYSTEAMINE BITARTRATE
RxCUI 81990
Orange Book
N020392
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "QO84GZ3TST",
"rxcui": "81990",
"inchikey": "NSKJTUFFDRENDM-ZVGUSBNCSA-N",
"display_name": "CYSTEAMINE BITARTRATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"f495b76d-96c6-48e5-8fa3-30a4336628eb": {
"match": "brand_token",
"title": "CYSTAGON (CYSTEAMINE BITARTRATE) CAPSULE [MYLAN PHARMACEUTICALS INC.]",
"spl_version": "13",
"published_date": "2024-12-16"
}
},
"productid": "0378-9045_29dfd298-96ed-4a5f-a573-b24f5ffa618b",
"productndc": "0378-9045",
"dosage_form": "CAPSULE",
"orange_book": {
"appl_no": "020392",
"products": [
{
"rs": false,
"rld": true,
"te_code": null,
"strength": "EQ 50MG BASE",
"product_no": "001",
"approval_date": "Aug 15, 1994"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 150MG BASE",
"product_no": "002",
"approval_date": "Aug 15, 1994"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYSTEAMINE BITARTRATE",
"proprietary_name": "Cystagon",
"active_ingred_unit": "mg/1",
"application_number": "NDA020392",
"marketing_category": "NDA",
"nonproprietary_name": "cysteamine bitartrate",
"start_marketing_date": "20050411",
"active_numerator_strength": "150"
}Related drugs
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