Prescription drug · NDA
Rayaldee (Calcifediol) NDC 70301-1001
Calcifediol 30 ug/1 · Capsule, Extended release · Oral · OPKO Pharmaceuticals LLC
NDC codes
FDA NDC Directory| Package NDC | 11-digit (billing) | Package | Copy |
|---|---|---|---|
| 70301-1001-1 | 70301100101 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1)Marketed from Oct 25, 2016 | |
| 70301-1001-2 | 70301100102 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2)Marketed from Oct 25, 2016 | |
| 70301-1001-3 | 70301100103 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3)Marketed from Feb 1, 2021 · Sample package |
How the 11-digit form is made: The package segment has 1 digit, so one leading zero is added to it (5-4-1 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules
Product information
- Brand name (proprietary)
- Rayaldee
- Generic name (nonproprietary)
- calcifediol
- Active ingredients
- Calcifediol — 30 ug/1
- Dosage form
- Capsule, Extended release
- Route
- Oral
- Labeler
- OPKO Pharmaceuticals LLCNDC labeler code 70301
- Product type
- Prescription drug
- Marketing category
- NDA — New Drug ApplicationApplication NDA 208010
- Marketing start
- Listing expires
- Other FDA classes
- Cholecalciferol (Chemical structure)
- Identifiers
- Product ID 70301-1001_7a2aae40-1f27-460f-bc3b-7227ce031d4eSPL ID 7a2aae40-1f27-460f-bc3b-7227ce031d4eSPL set ID 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77RxCUI 1855066, 1855072UNII P6YZ13C99QUPC 0370301100113
- Pharmacologic class
- Vitamin D3 Analog
Billing references
What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.
- HCPCS codeNo match
No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.
- NDC on a medical claim
N470301100101followed by a unit qualifier and the quantityPackage 70301-1001-01. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier
Product label
Current FDA label (SPL), effective .
Indications (excerpt from the label)
RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adult patients with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. Limitations of Use RAYALDEE is not indicated for the treatment of secondary hyperparathyroidism in patients with stage 5 chronic kidney disease or in patients with end-stage renal disease on dialysis. RAYALDEE is a vitamin D 3 analog indicated for the treatment of secondary hyperparathyroidism in adults with stage 3 or 4 chronic kidney disease and serum total 25-hydroxyvitamin D levels less than 30 ng/mL. ( 1 ) Limitations of Use: RAYALDEE is not indicated in patients with stage …
Excerpt only. Read the full label for complete information.
About NDC 70301-1001
- What is NDC 70301-1001?
- 70301-1001 is the product NDC for Rayaldee (calcifediol), Calcifediol 30 ug/1 capsule, extended release, listed with the FDA by OPKO Pharmaceuticals LLC. It has 3 package NDCs, shown above in 10- and 11-digit form.
- What drug is associated with this NDC?
- Rayaldee (Calcifediol).
- What is the active ingredient?
- Calcifediol.
- Who is the labeler?
- OPKO Pharmaceuticals LLC, NDC labeler code 70301. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
- What other NDCs exist for Rayaldee?
- 1 other product NDC are listed under this name. See all Rayaldee NDCs.
- Is there a related HCPCS / J-code?
- Not in Med-Code's curated HCPCS directory. See Billing references above.
Related NDCs: other Rayaldee products
Other finished products listed under the same name: strengths, forms and labelers.
| Product | Strength | Form · route | Labeler | Product NDC | Package NDCs (11-digit) |
|---|---|---|---|---|---|
| Rayaldeecalcifediol | Calcifediol 30 ug/1 | Capsule, Extended releaseOral | OPKO Pharmaceuticals LLC | 70301-1002 | 70301-1002-0170301-1002-0270301-1002-03 |
Other NDCs under NDA 208010
Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.
| Product | Strength | Form · route | Labeler | Product NDC |
|---|---|---|---|---|
| Rayaldeecalcifediol | Calcifediol 30 ug/1 | Capsule, Extended releaseOral | OPKO Pharmaceuticals LLC | 70301-1002 |