Doxercalciferol

Product NDC
71288-802
11-digit product format
712880802
Labeler code
71288
Product ID
71288-802_76c7152a-bbff-478d-9a21-a67e1411c61b
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxercalciferol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Meitheal Pharmaceuticals Inc.
Application
ANDA211670
Marketing category
ANDA
Marketing start
2020-02-11
Substance
DOXERCALCIFEROL
Active strength
4 ug/2mL
Pharmacologic classes
Ergocalciferols [CS], Vitamin D2 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
Doxercalciferol
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXERCALCIFEROL4 ug/2mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii3DIZ9LF5Y9
Rxcui282609

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
6d09ee63-cbd8-4742-9f11-2e20c9f8cd54Product name720240722
de957a3a-b26a-1797-ad5b-e5b01f363505Product name320210511
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71288-802-02Doxercalciferol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26
71288-802-03Doxercalciferol50 in 1 CARTONINJECTION, SOLUTION506
71288-802-04Doxercalciferol25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71288-802-02ML - Milliliter71288-802cba1437c-9bca-44f3-a0d1-f1943f90681012020-07-13
71288-802-03ML - Milliliter71288-802532fc6e1-832c-4c58-89fa-73710aa988bc12020-07-13
71288-802-04ML - Milliliter71288-8028f614fd2-f29e-4c60-8ba0-7eee1645778612022-08-04

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71288-802DOXERCALCIFEROL INJECTION, SOLUTION [MEITHEAL PHARMACEUTICALS INC.]6Current NDC, Legacy NDC, 3 package rows20240821_81a30e4b-be74-41d6-8277-b4f0ea5c15bc.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282609doxercalciferol 2 MCG/ML Injectable SolutionPSN81a30e4b-be74-41d6-8277-b4f0ea5c15bc6
282609doxercalciferol 0.002 MG/ML Injectable SolutionSCD81a30e4b-be74-41d6-8277-b4f0ea5c15bc6
282609doxercalciferol 2 MCG/ML Injectable SolutionSY81a30e4b-be74-41d6-8277-b4f0ea5c15bc6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71288-802-02712880802022 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
71288-802-037128808020350 VIAL, MULTI-DOSE in 1 CARTON (71288-802-03) > 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02) 2020-02-110000-00-00NoNoCurrent
71288-802-047128808020425 VIAL, MULTI-DOSE in 1 CARTON (71288-802-04) / 2 mL in 1 VIAL, MULTI-DOSE (71288-802-02) 2022-02-090000-00-00NoNoCurrent