🇺🇸
United States · US · US:15370-150_3affdd03-252d-443c-9966-e3aec314fb98
RYCLORA
Orange BookUNIISPLATC R06AB02
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerCARWIN PHARMACEUTICAL ASSOCIATES, LLC
CountryUS (United States)
ATC codeR06AB02
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc111537015004118 mL in 1 BOTTLE, PLASTIC (15370-150-04)
- ndc111537015016473 mL in 1 BOTTLE, PLASTIC (15370-150-16)
- ndc11153701509920 mL in 1 BOTTLE, PLASTIC (15370-150-99)
Annotations
UNII (FDA Substance ID)
B10YD955QW
DEXCHLORPHENIRAMINE MALEATE
RxCUI 54828
Orange Book
A202520
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "B10YD955QW",
"rxcui": "54828",
"inchikey": "DBAKFASWICGISY-DASCVMRKSA-N",
"display_name": "DEXCHLORPHENIRAMINE MALEATE",
"substance_type": "chemical",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"aa4f80c9-e600-4bc0-8528-02a8162a36f0": {
"match": "brand_token",
"title": "RYCLORA (DEXCHLORPHENIRAMINE MALEATE) LIQUID [CARWIN PHARMACEUTICAL ASSOCIATES, LLC]",
"spl_version": "2",
"published_date": "2024-01-09"
}
},
"productid": "15370-150_3affdd03-252d-443c-9966-e3aec314fb98",
"productndc": "15370-150",
"dosage_form": "LIQUID",
"orange_book": {
"appl_no": "202520",
"products": [
{
"rs": true,
"rld": false,
"te_code": null,
"strength": "2MG/5ML",
"product_no": "001",
"approval_date": "Jul 16, 2018"
}
],
"appl_type": "A"
},
"dea_schedule": null,
"product_type": "HUMAN PRESCRIPTION DRUG",
"substance_name": "DEXCHLORPHENIRAMINE MALEATE",
"proprietary_name": "RYCLORA",
"active_ingred_unit": "mg/5mL",
"application_number": "ANDA202520",
"marketing_category": "ANDA",
"nonproprietary_name": "Dexchlorpheniramine Maleate",
"start_marketing_date": "20181007",
"active_numerator_strength": "2"
}Related drugs
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- NODexclorfeniramina Maleato accordAccord
- 🇪🇸DEXCLORFENIRAMINA MALEATO ACCORD 5mg/ml SOLUCION INYECTABLE EFGAccord Healthcare S.L.U.
- FIPolaraminSchering-Plough Labo N.V.
- FIPolaramin ProlongatSchering-Plough Labo N.V.
- NOPolaramineSchering-Plough (4)
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