Doxercalciferol

Product NDC
62332-690
11-digit product format
623320690
Labeler code
62332
Product ID
62332-690_e253acbe-299e-4244-8c96-181d26feea3c
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Doxercalciferol
Dosage form
INJECTION, SOLUTION
Route
INTRAVENOUS
Labeler
Alembic Pharmaceuticals Inc.
Application
ANDA215810
Marketing category
ANDA
Marketing start
2023-06-15
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
62332-690-02Doxercalciferol2 mL in 1 VIAL, MULTI-DOSEINJECTION, SOLUTION26
62332-690-30Doxercalciferol50 in 1 CARTONINJECTION, SOLUTION506
62332-690-50Doxercalciferol25 in 1 CARTONINJECTION, SOLUTION256

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62332-690DOXERCALCIFEROL INJECTION, SOLUTION [ALEMBIC PHARMACEUTICALS INC.]6Current NDC, 3 package rows20240711_7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
282609doxercalciferol 2 MCG/ML Injectable SolutionPSN7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a6
282609doxercalciferol 0.002 MG/ML Injectable SolutionSCD7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a6
282609doxercalciferol 2 MCG/ML Injectable SolutionSY7d07fa4f-f2a2-4c2b-86bf-c0a4691c1a0a6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
62332-690-02623320690022 mL in 1 VIAL, MULTI-DOSE2 mlHistorical
62332-690-306233206903050 VIAL, MULTI-DOSE in 1 CARTON (62332-690-30) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02) 2023-06-15NoNoCurrent
62332-690-506233206905025 VIAL, MULTI-DOSE in 1 CARTON (62332-690-50) / 2 mL in 1 VIAL, MULTI-DOSE (62332-690-02) 2023-06-15NoNoCurrent