FDA.reportPublic FDA data

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

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
70301-1002-1Rayaldee30 in 1 BOTTLECAPSULE, EXTENDED RELEASE3010
70301-1002-2Rayaldee60 in 1 BOTTLECAPSULE, EXTENDED RELEASE6010
70301-1002-3Rayaldee7 in 1 BOTTLECAPSULE, EXTENDED RELEASE710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70301-1002-1EA - Each70301-100266f23c0b-209a-402d-aea8-4417a71df9d412024-03-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70301-1002RAYALDEE (CALCIFEDIOL) CAPSULE, EXTENDED RELEASE [OPKO PHARMACEUTICALS LLC]10Current 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 startSampleExclude flagStatus
70301-1002-17030110020130 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-1) 2024-03-11NoNoHistorical
70301-1002-27030110020260 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-2) 2024-03-11NoNoHistorical
70301-1002-3703011002037 CAPSULE, EXTENDED RELEASE in 1 BOTTLE (70301-1002-3) 2024-03-11YesNoHistorical