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United States · US · US:55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95
CYSTADROPS
Orange BookUNIISPLATC A16AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerRECORDATI RARE DISEASES, INC.
CountryUS (United States)
ATC codeA16AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc1155292410051 BOTTLE, GLASS in 1 BOX (55292-410-05) / 5 mL in 1 BOTTLE, GLASS
Annotations
UNII (FDA Substance ID)
IF1B771SVB
CYSTEAMINE HYDROCHLORIDE
RxCUI 1426886
Orange Book
N211302
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "IF1B771SVB",
"rxcui": "1426886",
"inchikey": "OGMADIBCHLQMIP-UHFFFAOYSA-N",
"display_name": "CYSTEAMINE HYDROCHLORIDE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "OPHTHALMIC",
"spl_meta": {
"5d2bcce3-9b89-4141-aeb7-db00449047f5": {
"match": "brand_token",
"title": "CYSTADROPS (CYSTEAMINE HYDROCHLORIDE) SOLUTION [RECORDATI RARE DISEASES, INC.]",
"spl_version": "5",
"published_date": "2025-06-13"
}
},
"productid": "55292-410_34dba967-28b4-4fc8-876d-2e30d32a0f95",
"productndc": "55292-410",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "211302",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.37% BASE",
"product_no": "001",
"approval_date": "Aug 19, 2020"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYSTEAMINE HYDROCHLORIDE",
"proprietary_name": "CYSTADROPS",
"active_ingred_unit": "mg/mL",
"application_number": "NDA211302",
"marketing_category": "NDA",
"nonproprietary_name": "cysteamine hydrochloride",
"start_marketing_date": "20200819",
"active_numerator_strength": "3.5"
}Related drugs
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