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United States · US · US:70301-1001_ab6d1f99-2dfe-4392-9fd8-cf0ffcec63ee

Rayaldee

Orange BookUNIISPLATC A11CC06

Last synced from FDA National Drug Code directory (United States) on

Identification

ManufacturerOPKO Pharmaceuticals LLC
CountryUS (United States)
ATC codeA11CC06
Dispensing
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026

Packs · 3

  • ndc11
    7030110011
    30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)
  • ndc11
    7030110012
    60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)
  • ndc11
    7030110013
    7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3)

Annotations

UNII (FDA Substance ID)
P6YZ13C99Q
CALCIFEDIOL
RxCUI 1889
Orange Book
N208010
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
  "unii": {
    "unii": "P6YZ13C99Q",
    "rxcui": "1889",
    "inchikey": "WRLFSJXJGJBFJQ-WPUCQFJDSA-N",
    "display_name": "CALCIFEDIOL",
    "substance_type": "chemical",
    "ingredient_type": "INGREDIENT SUBSTANCE"
  },
  "route": "ORAL",
  "spl_meta": {
    "6a95effd-32a5-46b6-a30e-7f4f9bf8cc77": {
      "match": "brand_token",
      "title": "RAYALDEE (CALCIFEDIOL) CAPSULE, EXTENDED RELEASE [OPKO PHARMACEUTICALS LLC]",
      "spl_version": "10",
      "published_date": "2025-01-13"
    }
  },
  "productid": "70301-1001_ab6d1f99-2dfe-4392-9fd8-cf0ffcec63ee",
  "productndc": "70301-1001",
  "dosage_form": "CAPSULE, EXTENDED RELEASE",
  "orange_book": {
    "appl_no": "208010",
    "products": [
      {
        "rs": true,
        "rld": true,
        "te_code": null,
        "strength": "0.03MG",
        "product_no": "001",
        "approval_date": "Jun 17, 2016"
      }
    ],
    "appl_type": "N"
  },
  "dea_schedule": null,
  "product_type": "HUMAN PRESCRIPTION DRUG",
  "substance_name": "CALCIFEDIOL",
  "proprietary_name": "Rayaldee",
  "active_ingred_unit": "ug/1",
  "application_number": "NDA208010",
  "marketing_category": "NDA",
  "nonproprietary_name": "calcifediol",
  "start_marketing_date": "20161025",
  "active_numerator_strength": "30"
}

Related drugs

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