Rayaldee
- Product NDC
- 70301-1001
- 11-digit product format
- 703011001
- Labeler code
- 70301
- Product ID
- 70301-1001_7a2aae40-1f27-460f-bc3b-7227ce031d4e
- 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
- 2016-10-25
- Substance
- CALCIFEDIOL
- Active strength
- 30 ug/1
- Pharmacologic classes
- Cholecalciferol [CS], Vitamin D3 Analog [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N208010-001 | RAYALDEE | CALCIFEDIOL | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 |
Orange Book patents#
| Application-product | Patent | Expiration | Use code | Coverage / status | Submission date |
|---|---|---|---|---|---|
| N208010-001 | 10213442 | 2027-02-02 | Drug product | 2019-03-06 | |
| N208010-001 | 8906410 | 2027-02-02 | Drug product | 2016-07-06 | |
| N208010-001 | 9943530 | 2027-02-02 | U-2274 | 2018-05-01 | |
| N208010-001 | 11154509 | 2028-04-25 | U-3815 | 2021-11-17 | |
| N208010-001 | 8207149 | 2028-04-25 | U-1871 | 2016-07-06 | |
| N208010-001 | 8778373 | 2028-04-25 | U-1873 | 2016-07-06 | |
| N208010-001 | 9408858 | 2028-04-25 | U-1888 | 2016-08-16 | |
| N208010-001 | 9498486 | 2028-04-25 | U-3814 | 2016-12-06 | |
| N208010-001 | 9925147 | 2028-04-25 | U-2255 | Drug product | 2018-04-09 |
| N208010-001 | 9925147 | 2028-04-25 | U-2256 | Drug product | 2018-04-09 |
| N208010-001 | 9925147 | 2028-04-25 | U-2257 | Drug product | 2018-04-09 |
| N208010-001 | 9925147 | 2028-04-25 | U-2258 | Drug product | 2018-04-09 |
| N208010-001 | 9925147 | 2028-04-25 | U-2259 | Drug product | 2018-04-09 |
| N208010-001 | 8361488 | 2028-07-19 | Drug product | 2016-07-06 | |
| N208010-001 | 8426391 | 2028-08-27 | U-1872 | 2016-07-06 | |
| N208010-001 | 11801253 | 2030-09-07 | U-3721 | Drug product | 2023-11-02 |
| N208010-001 | 11801253 | 2030-09-07 | U-3722 | Drug product | 2023-11-02 |
| N208010-001 | 11801253 | 2030-09-07 | U-3723 | Drug product | 2023-11-02 |
| N208010-001 | 10300078 | 2034-03-14 | Drug product | 2019-06-18 | |
| N208010-001 | 10357502 | 2034-03-14 | Drug product | 2019-08-09 | |
| N208010-001 | 11253528 | 2034-03-14 | Drug product | 2022-03-04 | |
| N208010-001 | 9861644 | 2034-03-14 | Drug product | 2018-01-23 |
Observed Orange Book product history#
Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | 3a93d1ddd44b… | |
| 2022-10-28 04:53 UTC | 2022-10 | N208010-001 | RAYALDEE | 0.03MG | CAPSULE, EXTENDED RELEASE / ORAL | RLD, RS | 2016-06-17 | f41ea6bd6efb… |
Observed Orange Book patent history#
| Captured | Edition | Application-product | Patent | Expiration | Use code | Coverage / status | Submission date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 10213442 | 2027-02-02 | Drug product | 2019-03-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 8906410 | 2027-02-02 | Drug product | 2016-07-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9943530 | 2027-02-02 | U-2274 | 2018-05-01 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 11154509 | 2028-04-25 | U-3815 | 2021-11-17 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 8207149 | 2028-04-25 | U-1871 | 2016-07-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 8778373 | 2028-04-25 | U-1873 | 2016-07-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9408858 | 2028-04-25 | U-1888 | 2016-08-16 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9498486 | 2028-04-25 | U-3814 | 2016-12-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9925147 | 2028-04-25 | U-2258 | Drug product | 2018-04-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9925147 | 2028-04-25 | U-2255 | Drug product | 2018-04-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9925147 | 2028-04-25 | U-2256 | Drug product | 2018-04-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9925147 | 2028-04-25 | U-2257 | Drug product | 2018-04-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9925147 | 2028-04-25 | U-2259 | Drug product | 2018-04-09 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 8361488 | 2028-07-19 | Drug product | 2016-07-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 8426391 | 2028-08-27 | U-1872 | 2016-07-06 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 11801253 | 2030-09-07 | U-3721 | Drug product | 2023-11-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 11801253 | 2030-09-07 | U-3722 | Drug product | 2023-11-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 11801253 | 2030-09-07 | U-3723 | Drug product | 2023-11-02 | 84e616aacf4f… |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 10300078 | 2034-03-14 | Drug product | 2019-06-18 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 10357502 | 2034-03-14 | Drug product | 2019-08-09 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 11253528 | 2034-03-14 | Drug product | 2022-03-04 | 84e616aacf4f… | |
| 2026-09-14 22:38:34 | 2026-08 | N208010-001 | 9861644 | 2034-03-14 | Drug product | 2018-01-23 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 10213442 | 2027-02-02 | Drug product | 2019-03-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 8906410 | 2027-02-02 | Drug product | 2016-07-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9943530 | 2027-02-02 | U-2274 | 2018-05-01 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 11154509 | 2028-04-25 | U-3815 | 2021-11-17 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 8207149 | 2028-04-25 | U-1871 | 2016-07-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 8778373 | 2028-04-25 | U-1873 | 2016-07-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9408858 | 2028-04-25 | U-1888 | 2016-08-16 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9498486 | 2028-04-25 | U-3814 | 2016-12-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9925147 | 2028-04-25 | U-2258 | Drug product | 2018-04-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9925147 | 2028-04-25 | U-2255 | Drug product | 2018-04-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9925147 | 2028-04-25 | U-2256 | Drug product | 2018-04-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9925147 | 2028-04-25 | U-2257 | Drug product | 2018-04-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 9925147 | 2028-04-25 | U-2259 | Drug product | 2018-04-09 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 8361488 | 2028-07-19 | Drug product | 2016-07-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 8426391 | 2028-08-27 | U-1872 | 2016-07-06 | caaa826d4ba7… | |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 11801253 | 2030-09-07 | U-3721 | Drug product | 2023-11-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 11801253 | 2030-09-07 | U-3722 | Drug product | 2023-11-02 | caaa826d4ba7… |
| 2026-08-18 06:07:40 | 2026-07 | N208010-001 | 11801253 | 2030-09-07 | U-3723 | Drug product | 2023-11-02 | caaa826d4ba7… |
Observed Orange Book exclusivity history#
| Captured | Edition | Application-product | Exclusivity code | Expiration | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | N208010-001 | NP | 2019-06-17 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | N208010-001 | NP | 2019-06-17 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | N208010-001 | NP | 2019-06-17 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | N208010-001 | NP | 2019-06-17 | ea99ee380514… |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Rayaldee
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| CALCIFEDIOL | 30 ug/1 |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| P6YZ13C99Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 87caf3aa-c849-40ce-ba4c-06b2786c867c | Product name | 1 | 20160808 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 70301-1001-1 | Rayaldee | 30 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 30 | 10 | |
| 70301-1001-2 | Rayaldee | 60 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 60 | 10 | |
| 70301-1001-3 | Rayaldee | 7 in 1 BOTTLE | CAPSULE, EXTENDED RELEASE | 7 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 70301-1001-1 | EA - Each | 70301-1001 | 25dfca4c-25ac-4a32-9eb3-87373366e3e3 | 1 | 2016-12-07 |
| 70301-1001-2 | EA - Each | 70301-1001 | 95cbbca4-0689-4221-b47a-d2f0e444327b | 1 | 2016-12-07 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70301-1001 | RAYALDEE (CALCIFEDIOL) CAPSULE, EXTENDED RELEASE [OPKO PHARMACEUTICALS LLC] | 10 | Current NDC, Legacy NDC, 3 package rows | 20250112_6a95effd-32a5-46b6-a30e-7f4f9bf8cc77.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Rayaldee | CALCIFEDIOL | OPKO Pharmaceuticals LLC | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 2024-01-19 | Warnings, Adverse reactions | 208010 NDA208010 70301-1001 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1855066 | calcifediol 30 MCG 24HR Extended Release Oral Capsule | PSN | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855072 | Rayaldee 30 MCG 24HR Extended Release Oral Capsule | PSN | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855072 | 24 HR calcifediol 0.03 MG Extended Release Oral Capsule [Rayaldee] | SBD | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855066 | 24 HR calcifediol 0.03 MG Extended Release Oral Capsule | SCD | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855072 | 24 HR Rayaldee 0.03 MG Extended Release Oral Capsule | SY | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855066 | calcifediol 30 MCG 24HR Extended Release Oral Capsule | SY | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
| 1855072 | Rayaldee 30 MCG 24HR Extended Release Oral Capsule | SY | 6a95effd-32a5-46b6-a30e-7f4f9bf8cc77 | 10 |
Packages#
| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 70301-1001-1 | 70301100101 | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1) | 2016-10-25 | 0000-00-00 | No | No | Current |
| 70301-1001-2 | 70301100102 | 60 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2) | 2016-10-25 | 0000-00-00 | No | No | Current |
| 70301-1001-3 | 70301100103 | 7 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3) | 2021-02-01 | 0000-00-00 | Yes | No | Current |