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

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208010-001RAYALDEECALCIFEDIOL0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17

Orange Book patents#

Current patent rows page 1 of 1 · 22 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N208010-001102134422027-02-02Drug product2019-03-06
N208010-00189064102027-02-02Drug product2016-07-06
N208010-00199435302027-02-02U-22742018-05-01
N208010-001111545092028-04-25U-38152021-11-17
N208010-00182071492028-04-25U-18712016-07-06
N208010-00187783732028-04-25U-18732016-07-06
N208010-00194088582028-04-25U-18882016-08-16
N208010-00194984862028-04-25U-38142016-12-06
N208010-00199251472028-04-25U-2255Drug product2018-04-09
N208010-00199251472028-04-25U-2256Drug product2018-04-09
N208010-00199251472028-04-25U-2257Drug product2018-04-09
N208010-00199251472028-04-25U-2258Drug product2018-04-09
N208010-00199251472028-04-25U-2259Drug product2018-04-09
N208010-00183614882028-07-19Drug product2016-07-06
N208010-00184263912028-08-27U-18722016-07-06
N208010-001118012532030-09-07U-3721Drug product2023-11-02
N208010-001118012532030-09-07U-3722Drug product2023-11-02
N208010-001118012532030-09-07U-3723Drug product2023-11-02
N208010-001103000782034-03-14Drug product2019-06-18
N208010-001103575022034-03-14Drug product2019-08-09
N208010-001112535282034-03-14Drug product2022-03-04
N208010-00198616442034-03-14Drug product2018-01-23

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1784e616aacf4f…
2026-08-18 06:07:402026-07N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-173f01610625f2…
2019-09-15 20:21 UTC2019-09N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N208010-001RAYALDEE0.03MGCAPSULE, EXTENDED RELEASE / ORALRLD, RS2016-06-17f41ea6bd6efb…

Observed Orange Book patent history#

Patent history page 1 of 22 · 867 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-09-14 22:38:342026-08N208010-001102134422027-02-02Drug product2019-03-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00189064102027-02-02Drug product2016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199435302027-02-02U-22742018-05-0184e616aacf4f…
2026-09-14 22:38:342026-08N208010-001111545092028-04-25U-38152021-11-1784e616aacf4f…
2026-09-14 22:38:342026-08N208010-00182071492028-04-25U-18712016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00187783732028-04-25U-18732016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00194088582028-04-25U-18882016-08-1684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00194984862028-04-25U-38142016-12-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199251472028-04-25U-2258Drug product2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199251472028-04-25U-2255Drug product2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199251472028-04-25U-2256Drug product2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199251472028-04-25U-2257Drug product2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-00199251472028-04-25U-2259Drug product2018-04-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-00183614882028-07-19Drug product2016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-00184263912028-08-27U-18722016-07-0684e616aacf4f…
2026-09-14 22:38:342026-08N208010-001118012532030-09-07U-3721Drug product2023-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N208010-001118012532030-09-07U-3722Drug product2023-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N208010-001118012532030-09-07U-3723Drug product2023-11-0284e616aacf4f…
2026-09-14 22:38:342026-08N208010-001103000782034-03-14Drug product2019-06-1884e616aacf4f…
2026-09-14 22:38:342026-08N208010-001103575022034-03-14Drug product2019-08-0984e616aacf4f…
2026-09-14 22:38:342026-08N208010-001112535282034-03-14Drug product2022-03-0484e616aacf4f…
2026-09-14 22:38:342026-08N208010-00198616442034-03-14Drug product2018-01-2384e616aacf4f…
2026-08-18 06:07:402026-07N208010-001102134422027-02-02Drug product2019-03-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00189064102027-02-02Drug product2016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199435302027-02-02U-22742018-05-01caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-001111545092028-04-25U-38152021-11-17caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00182071492028-04-25U-18712016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00187783732028-04-25U-18732016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00194088582028-04-25U-18882016-08-16caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00194984862028-04-25U-38142016-12-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199251472028-04-25U-2258Drug product2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199251472028-04-25U-2255Drug product2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199251472028-04-25U-2256Drug product2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199251472028-04-25U-2257Drug product2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00199251472028-04-25U-2259Drug product2018-04-09caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00183614882028-07-19Drug product2016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-00184263912028-08-27U-18722016-07-06caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-001118012532030-09-07U-3721Drug product2023-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-001118012532030-09-07U-3722Drug product2023-11-02caaa826d4ba7…
2026-08-18 06:07:402026-07N208010-001118012532030-09-07U-3723Drug product2023-11-02caaa826d4ba7…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N208010-001NP2019-06-1774a2ff9319b5…
2019-12-14 00:12 UTC2019-12N208010-001NP2019-06-173f01610625f2…
2019-09-15 20:21 UTC2019-09N208010-001NP2019-06-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N208010-001NP2019-06-17ea99ee380514…

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 table
IngredientStrength
CALCIFEDIOL30 ug/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
P6YZ13C99QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1855066Internal RxNorm lookup
1855072Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
6a95effd-32a5-46b6-a30e-7f4f9bf8cc77Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
87caf3aa-c849-40ce-ba4c-06b2786c867cProduct name120160808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70301-1001-1Rayaldee30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
70301-1001-2Rayaldee60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6010
70301-1001-3Rayaldee7 in 1 BOTTLECAPSULE, EXTENDED RELEASE710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70301-1001-1EA - Each70301-100125dfca4c-25ac-4a32-9eb3-87373366e3e312016-12-07
70301-1001-2EA - Each70301-100195cbbca4-0689-4221-b47a-d2f0e444327b12016-12-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70301-1001RAYALDEE (CALCIFEDIOL) CAPSULE, EXTENDED RELEASE [OPKO PHARMACEUTICALS LLC]10Current NDC, Legacy NDC, 3 package rows20250112_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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
RayaldeeCALCIFEDIOLOPKO Pharmaceuticals LLC6a95effd-32a5-46b6-a30e-7f4f9bf8cc772024-01-19Warnings, Adverse reactionsExact identifier
application applno (NDA): 208010
application number: NDA208010
ndc (product): 70301-1001

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1855066calcifediol 30 MCG 24HR Extended Release Oral CapsulePSN6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
1855072Rayaldee 30 MCG 24HR Extended Release Oral CapsulePSN6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
185507224 HR calcifediol 0.03 MG Extended Release Oral Capsule [Rayaldee]SBD6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
185506624 HR calcifediol 0.03 MG Extended Release Oral CapsuleSCD6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
185507224 HR Rayaldee 0.03 MG Extended Release Oral CapsuleSY6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
1855066calcifediol 30 MCG 24HR Extended Release Oral CapsuleSY6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710
1855072Rayaldee 30 MCG 24HR Extended Release Oral CapsuleSY6a95effd-32a5-46b6-a30e-7f4f9bf8cc7710

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
70301-1001-17030110010130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-1) 2016-10-250000-00-00NoNoCurrent
70301-1001-27030110010260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-2) 2016-10-250000-00-00NoNoCurrent
70301-1001-3703011001037 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1001-3) 2021-02-010000-00-00YesNoCurrent