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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

  • ndc11
    1537015004
    118 mL in 1 BOTTLE, PLASTIC (15370-150-04)
  • ndc11
    1537015016
    473 mL in 1 BOTTLE, PLASTIC (15370-150-16)
  • ndc11
    1537015099
    20 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

Other records sharing ATC code R06AB02.

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