Rayaldee Capsule, Extended Release
NDC 70301-1001

View dosage, usage, ingredients, routes, and UNII mappings.
Table of Contents
  1. Product Information
  2. Product Packages
  3. Product Characteristics
  4. What is NDC 70301-1001?
  5. Rayaldee Uses
  6. Active Ingredients
  7. Active Ingredients UNII Codes
  8. Inactive Ingredients UNII Codes
  9. NDC to RxNorm Crosswalk
  10. Pharmacologic Classes
  11. Patient Education

Product Information

Rayaldee (calcifediol) is a NDA-approved product labeled by Opko Pharmaceuticals Llc. This medication is used to treat people with serious kidney disease whose bodies make too much of a certain natural substance (parathyroid hormone-PTH). It is supplied as a blue capsule, extended release for oral administration. This product entry covers the primary NDC 70301-1001 and 3 associated package configurations. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
70301-1001
Proprietary Name:
Rayaldee
Non-Proprietary Name: [1]
Calcifediol
Substance Name: [2]
Calcifediol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Code Navigator:

Clinical Specifications

Dosage Form:
Capsule, Extended Release - A solid dosage form in which the drug is enclosed within either a hard or soft soluble container made from a suitable form of gelatin, and which releases a drug (or drugs) in such a manner to allow a reduction in dosing frequency as compared to that drug (or drugs) presented as a conventional dosage form.
Administration Route(s): [4]
Oral - Administration to or by way of the mouth.

Labeler & Regulatory Data

Labeler Name: [5]
Opko Pharmaceuticals Llc
Labeler Code:
70301
Product Label ID:
6a95effd-32a5-46b6-a30e-7f4f9bf8cc77
FDA Application Number: [6]
NDA208010
Marketing Category: [8]
NDA - A product marketed under an approved New Drug Application.

Marketing Timeline

Start Marketing Date: [9]
10-25-2016
Listing Expiration Date: [11]
12-31-2026
Exclude Flag: [12]
N

Product Characteristics

Color(s):
BLUE (C48333)
Shape:
OVAL (C48345)
Size(s):
12 MM
Imprint(s):
O
Score:
1

Code Structure Chart

Product Details

What is NDC 70301-1001?

The NDC code 70301-1001 is assigned by the FDA to the product Rayaldee. It is commonly known by its generic name, calcifediol. This pharmaceutical product is labeled by Opko Pharmaceuticals Llc and is currently categorized as listed product. The medication is a capsule, extended release administered via oral route. In terms of distribution, this product is available in 3 different package configurations. The associated package NDC(s) include: 70301-1001-1, 70301-1001-2, 70301-1001-3. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

This medication is used to treat people with serious kidney disease whose bodies make too much of a certain natural substance (parathyroid hormone-PTH). High amounts of PTH can affect other minerals in the body (such as calcium, phosphorus) that are needed for strong bones. Calcifediol belongs to a class of drugs known as vitamin D analogs. It works by decreasing PTH and increasing calcium and phosphorus in the body.

What are Active Ingredients of this product?

An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
  • CALCIFEDIOL 30 ug/1 - The major circulating metabolite of VITAMIN D3. It is produced in the LIVER and is the best indicator of the body's vitamin D stores. It is effective in the treatment of RICKETS and OSTEOMALACIA, both in azotemic and non-azotemic patients. Calcifediol also has mineralizing properties.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

What is the NDC to RxNorm Crosswalk for this product?

RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
  • RxCUI: 1855066 - calcifediol 30 MCG 24HR Extended Release Oral Capsule
  • RxCUI: 1855066 - 24 HR calcifediol 0.03 MG Extended Release Oral Capsule
  • RxCUI: 1855072 - Rayaldee 30 MCG 24HR Extended Release Oral Capsule
  • RxCUI: 1855072 - 24 HR calcifediol 0.03 MG Extended Release Oral Capsule [Rayaldee]
  • RxCUI: 1855072 - 24 HR Rayaldee 0.03 MG Extended Release Oral Capsule

Which are the Pharmacologic Classes of this product?

A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

* Please review the full disclaimer at the bottom of this page.

Patient Education

Calcifediol


Calcifediol is used to treat secondary hyperparathyroidism (a condition in which the body produces too much parathyroid hormone [PTH; a natural substance needed to control the amount of calcium in the blood], ) in certain adults with chronic kidney disease (condition in which the kidneys stop working slowly and gradually). Calcifediol is in a class of medications called vitamin D analogs. It works by helping the body to use more of the calcium found in foods or supplements and by regulating the body's production of parathyroid hormone.
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* Please review the full disclaimer at the bottom of this page.

Product & Regulatory Definitions
What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
What is the Substance Name? An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.
What kind of product is this? Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.
What are the Administration Routes? The translation of the route code submitted by the firm, indicating route of administration.
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".