NDC 70301-1001

Rayaldee

Calcifediol

Rayaldee is a Oral Capsule, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Opko Pharmaceuticals Llc. The primary component is Calcifediol.

• Product ID: 70301-1001_08c6e175-8d53-4d94-88ce-e864dccde0f1
• NDC: 70301-1001
• Product Type: Human Prescription Drug
• Proprietary Name: Rayaldee
• Generic Name: Calcifediol
• Dosage Form: Capsule, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2016-10-25
• Marketing Category: NDA / NDA
• Application Number: NDA208010
• Labeler Name: OPKO Pharmaceuticals LLC
• Substance Name: CALCIFEDIOL
• Active Ingredient Strength: 30 ug/1
• Pharm Classes: Cholecalciferol [CS],Vitamin D3 Analog [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 70301-1001-1

30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)

• Marketing Start Date: 2016-10-25
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 70301-1001-2 [70301100102]

Rayaldee CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208010
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-25

NDC 70301-1001-1 [70301100101]

Rayaldee CAPSULE, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA208010
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2016-10-25

Drug Details

Active Ingredients

Ingredient	Strength
CALCIFEDIOL	30 ug/1

OpenFDA Data

• SPL SET ID: 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77
• Manufacturer:
  • OPKO Pharmaceuticals LLC
• UNII:
  • P6YZ13C99Q
• RxNorm Concept Unique ID - RxCUI:
  • 1855066
  • 1855072
• UPC Code:
  • 0370301100120

Pharmacological Class

• Cholecalciferol [CS]
• Vitamin D3 Analog [EPC]

Medicade Reported Pricing

70301100102 RAYALDEE ER 30 MCG CAPSULE

Pricing Unit: EA | Drug Type:

70301100101 RAYALDEE ER 30 MCG CAPSULE

Pricing Unit: EA | Drug Type: