🇺🇸
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
- ndc11703011001130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)
- ndc11703011001260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)
- ndc1170301100137 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
Other records sharing ATC code A11CC06.
- 🇫🇷CALCIFEDIOL DESMA 15 mg/100 ml, solution buvable en gouttesDESMA PHARMA
- 🇪🇸CALCIFEDIOL FAES 0,266 MG CAPSULAS BLANDAS EFGFaes Farma S.A.
- IECalcifediol Faes 72 microgram soft capsulesFaes Farma S.A.
- 🇫🇷CALCIFEDIOL GERDA 15 mg/100 mL, solution buvable en gouttesSOCIETE ALEPT
- 🇪🇸CALCIFEDIOL NORMOGEN 0,266 MG CAPSULAS BLANDAS EFGLaboratorios Normon S.A.
- 🇪🇸CALCIFEDIOL NORMON 0,266 MG CAPSULAS BLANDAS EFGLaboratorios Normon S.A.
- PLCalfosBerlin-Chemie AG
- PLCalfosAllpharm Sp. z o.o. sp.k.
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