Rayaldee
- Product NDC
- 70301-1002
- 11-digit product format
- 703011002
- Labeler code
- 70301
- Product ID
- 70301-1002_ab6d1f99-2dfe-4392-9fd8-cf0ffcec63ee
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- calcifediol
- Dosage form
- CAPSULE, EXTENDED RELEASE
- Route
- ORAL
- Labeler
- OPKO Pharmaceuticals LLC
- Application
- NDA208010
- Marketing category
- NDA
- Marketing start
- 2024-03-11
- Substance
- CALCIFEDIOL
- Active strength
- 30 ug/1
- Pharmacologic classes
- Cholecalciferol [CS], Vitamin D3 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Related UNII Ingredients
| UNII | Preferred term | Registry number | Matched term |
|---|
| P6YZ13C99Q | CALCIFEDIOL | 63283-36-3 | CALCIFEDIOL |
Packages
| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 70301-1002-1 | 70301100201 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-1) | 2024-03-11 | No | No | Historical |
| 70301-1002-2 | 70301100202 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-2) | 2024-03-11 | No | No | Historical |
| 70301-1002-3 | 70301100203 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-3) | 2024-03-11 | Yes | No | Historical |
Related DailyMed Labels
| Title | Manufacturer | Effective date | Type | Version |
|---|
| Rayaldee | OPKO Pharmaceuticals LLC | 2024-01-19 | HUMAN PRESCRIPTION DRUG LABEL | 10 |