🇺🇸
United States · US · US:54482-020_0ae95603-411c-455b-8bb8-8c5b01dac297
CYSTARAN
Orange BookUNIISPLATC A16AA04
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerLeadiant Biosciences, Inc.
CountryUS (United States)
ATC codeA16AA04
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 1
- ndc11544820200215 mL in 1 BOTTLE (54482-020-02)
Annotations
UNII (FDA Substance ID)
IF1B771SVB
CYSTEAMINE HYDROCHLORIDE
RxCUI 1426886
Orange Book
N200740
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": {
"b98ee838-ed23-42a9-93b5-72579e490fba": {
"match": "brand_token",
"title": "CYSTARAN (CYSTEAMINE HYDROCHLORIDE) SOLUTION [LEADIANT BIOSCIENCES, INC.]",
"spl_version": "23",
"published_date": "2025-05-05"
}
},
"productid": "54482-020_0ae95603-411c-455b-8bb8-8c5b01dac297",
"productndc": "54482-020",
"dosage_form": "SOLUTION",
"orange_book": {
"appl_no": "200740",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "EQ 0.44% BASE",
"product_no": "001",
"approval_date": "Oct 2, 2012"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "CYSTEAMINE HYDROCHLORIDE",
"proprietary_name": "CYSTARAN",
"active_ingred_unit": "mg/mL",
"application_number": "NDA200740",
"marketing_category": "NDA",
"nonproprietary_name": "cysteamine hydrochloride",
"start_marketing_date": "20121230",
"active_numerator_strength": "6.5"
}Related drugs
Other records sharing ATC code A16AA04.
- 🇺🇸CYSTADROPSRECORDATI RARE DISEASES, INC.
- GBCystadrops 3.8mg/ml eye dropsRecordati Rare Diseases UK Ltd
- 🇮🇹CYSTADROPS*collirio 5 ml 3,8 mg/mlRECORDATI RARE DISEASES SARL
- PLCystagonRecordati Rare Diseases
- ISCystagonRecordati Rare Diseases*
- PLCystagonRecordati Rare Diseases
- 🇺🇸CystagonMylan Pharmaceuticals Inc.
- ISCystagonRecordati Rare Diseases*
Access this data programmatically
Query CYSTARAN and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.