FDA.reportPublic FDA data

Rayaldee

Product NDC
70301-1001
11-digit product format
703011001
Labeler code
70301
Product ID
70301-1001_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
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rayaldee
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CALCIFEDIOL30 ug/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiP6YZ13C99Q
Rxcui1855066, 1855072

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

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